The KISS Dynamic Solid Drop Seat and Back Support devices are wheelchair components intended for medical purposes that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part.

The KISS Dynamic Solid Drop Seat and Back Support are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seating platform or back support with dynamic motion.

Device Description

The KISS devices are wheelchair components intended for medical purposes generally sold as an integral part of a wheelchair but may also be sold separately as a replacement seat and back support. The KISS devices are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seat and back support with dynamic motion.

The KISS Seat consists of (1) a solid seating platform, (2) an adjustable seat frame, (3) pivot blocks, and (4) springs. The KISS seat replaces the standard cloth seat on a wheelchair frame. It attaches to the wheelchair with (5) four drop hooks and is locked in place with (6) securing hardware.

The KISS Back Support consists of (1) a lumbar support with (2) mounting brackets and (3) an upper back support with a solid ventilated (4) backrest. The lumbar support and the upper back support are hinged together with (5) springs therebetween. (6) Mounting hardware connects the KISS back support to the wheelchair frame in place of the standard cloth backrest. (7) A removable upholstered cover encases the back support assembly.

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for a medical device, the KISS Dynamic Solid Drop Seat and Back Support. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials for a novel technology.

Therefore, the document does not present a typical study proving a device meets specific acceptance criteria in the manner of a clinical trial for a new drug or a novel, high-risk device. Instead, it focuses on demonstrating that the performance characteristics of the KISS devices are similar to or better than predicate devices, and that they comply with relevant international standards for wheelchair components.

Here's an analysis of the available information in the context of your questions, noting where the information is absent due to the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" for clinical performance in the way you might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, it focuses on engineering specifications, safety standards, and comparative performance to predicates.

Here's a summary of the performance claims based on the described tests, which serve as the implicit "acceptance criteria" for substantial equivalence:

Performance Characteristic/Acceptance Criteria (Implied)	Reported Device Performance
ISO 16840-3 Compliance (Static, Impact, Repetitive Load Strengths for Postural Support Devices)	Passed.
RESNA WC-1 Compliance (Sections 1, 5 & 7 for static stability, maneuverability, dimensions, seating measurements) - when installed on a Quickie series wheelchair	*Static Stability: Increased on rearward incline (wheels locked), Decreased on rearward (wheels unlocked), forward, and lateral inclines. Maneuverability, Dimensions, Measurements: Not changed.
ISO 898-7 Compliance (Durability of clamping system and mechanical fasteners)	Passed. (Selected securing hardware tested)
Loaded Deflection Test (Optimal spring placement for KISS seat)	Springs should be positioned under the pelvis and not exceed one adjustment position (1") to either side.
Influence on Wheelchair Cushion's Force-Deflection relationship (Addressing off-loading concerns)	User lifts an additional 0.4" to fully offload from the wheelchair cushion. (Implied acceptable off-loading)
Wheelchair Compatibility (Fitting standard wheelchairs)	Fits standard folding manual wheelchairs; does not fit ultralight models due to rigid frame design.
ISO 10993-10 Biocompatibility (Cytotoxicity, skin irritation, sensitization for upholstered cover)	Passed.
ISO 16840-10 Resistance to Ignition (Upholstered cover)	Test #1 passed. Test #2 failed (continued to emit visible smoke for 30s vs. standard's 20s limit).
Interface Pressure (Clinical Testing)	Does not negatively affect interface pressure; reduced peak interface pressures measured during propulsion.

Important Note: The "acceptance criteria" here are largely implicit from the standards the device was tested against and its mechanical properties relative to predicates, rather than strict clinical outcome thresholds (like symptom reduction or disease progression). The failure on one part of the ISO 16840-10 test is noted, but the overall conclusion still asserts substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

For mechanical and engineering tests (ISO, RESNA, bench tests), "sample size" typically refers to the number of devices or components tested. The document doesn't provide specific numbers (e.g., "3 units were tested for ISO 16840-3"). It simply states "The KISS devices passed..." For the "Influences of the KISS dynamic seat on a Wheelchair Cushion's Force-Deflection relationship" and "Wheelchair Compatibility," it implies single or small numbers of tests rather than a large "dataset."

For the clinical testing for interface pressure, the document mentions "Clinical testing indicates..." but provides no details on:

Sample Size: Not stated.
Data Provenance: Not stated (e.g., country of origin, retrospective/prospective). Given the nature of a 510(k) for this type of device, it's highly likely it was a small, focused study, possibly done domestically. It is not presented as a large, multi-center trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This concept (experts establishing ground truth for a test set) is typically relevant for AI/ML devices that interpret images or signals, where human experts label the data. For a mechanical device like a wheelchair component, "ground truth" is established by:

Objective physical measurements: Performed by engineers and technicians according to standard protocols (e.g., measuring dimensions, force, deflection).
Standardized test methods: As defined by ISO or RESNA.
Predicate device specifications: Used for comparison.

Therefore, this section is not applicable in the traditional sense for this device.

4. Adjudication Method for the Test Set

Again, this is largely applicable to AI/ML or clinical imaging studies involving human readers. For mechanical testing, test results are typically objective, and adjudication (e.g., 2+1 reader consensus) is not performed.

Therefore, this section is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. An MRMC study is relevant for evaluating the impact of AI assistance on human readers' diagnostic performance (e.g., radiologists interpreting images with or without AI). This type of study was not conducted for the KISS devices as they are mechanical components, not diagnostic aids.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done.

This question is primarily for AI/ML algorithms. The KISS devices are mechanical. While they were tested as "standalone" components in some bench tests (e.g., ISO and RESNA tests are performed on the device itself or installed on a wheelchair frame, without a human user actively operating them as part of the test setup), it's not "algorithm only performance."

Therefore, this concept is not applicable in the context of AI.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily based on:

Engineering specifications and measurements: Directly measured physical properties of the devices.
Adherence to International Standards (ISO, RESNA): The device's performance is compared against predefined, objective pass/fail criteria from these standards.
Comparison to Predicate Devices: Demonstrating similar physical and performance characteristics to existing, legally marketed devices.
Limited Clinical Observation (Interface Pressure): The "clinical testing" mentioned likely involved measuring interface pressure under controlled conditions, with the "truth" being the pressure readings themselves, compared against previous data or industry understanding of acceptable pressure levels to prevent issues like pressure injuries. This would not typically involve "pathology" or "outcomes data" in the sense of long-term patient health outcomes for a 510(k) of a wheelchair component.

8. The Sample Size for the Training Set

This question applies to AI/ML models. The KISS devices are mechanical components and do not involve a "training set" in the machine learning sense.

Therefore, this section is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/ML model for this mechanical device, this question is not applicable.

In summary of the provided text:

The document serves as a 510(k) submission for a Class I wheelchair component. It demonstrates substantial equivalence primarily through:

Compliance with relevant mechanical and material standards (ISO, RESNA).
Bench testing to show physical characteristics and performance (e.g., deflection, compatibility).
Limited clinical observation (interface pressure) to ensure the device does not negatively impact user safety/comfort in this specific aspect.
Direct comparison of technical specifications and intended use with predicate and reference devices.

The "study" here is a combination of engineering and bench tests, with a small clinical observation for specific parameters, rather than a large-scale clinical trial to prove efficacy or diagnostic accuracy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 4, 2022

Kinetic Innovative Seating System LLC Susan Farricielli President / Managing Partner 26 N. Main Street, Office Bldg Branford, Connecticut 06405

Re: K211919

Trade/Device Name: KISS Dynamic Solid Drop Seat, Model S1520 KISS Dynamic Back Support, Model B1620 Regulation Number: 21 CFR 890.3920 Regulation Name: Wheelchair Component Regulatory Class: Class I Product Code: KNN Dated: December 11, 2021 Received: December 15, 2021

Dear Susan Farricielli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K211919

Device Name

KISS Dynamic Solid Drop Seat, Model S1520 KISS Dynamic Back Support, Model B1620

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for KISS, which stands for Kinetic Innovative Seating System, LLC. The logo features the word "Kiss" in a stylized font, with the "i" in "Kiss" being red. The rest of the letters are black. Below the logo is the full name of the company, "Kinetic Innovative Seating System, LLC".

Image /page/3/Picture/1 description: The image shows a diagram of a wheelchair with a red banner that reads "comfortable seating for wheelchairs". The wheelchair is drawn in a simple, technical style, with clean lines and minimal detail. The red banner is positioned horizontally across the image, partially obscuring the wheelchair's backrest.

510(k) SUMMARY

as required by 21CFR 807.92

KISS DYNAMIC SEATING SYSTEM (bundled devices): KISS SOLID DROP SEAT KISS DYNAMIC BACK SUPPORT K211919

Owner Information: Kinetic Innovative Seating System, LLC 26 N. Main Street, office bldg. Branford, CT 06405

Phone: (203) 488-1758 Fax: (203) 643-8006 Email: info@kissforwheelchairs.com Contact person: Susan Farricielli

Date of revised Summary preparation: February 23, 2022

Name of the devices:

Proprietary name(s) - KISS Dynamic Solid Drop Seat, Model S1520 KISS Dynamic Back Support, Model B1620

Common name(s) = drop seat / back support Classification name - wheelchair component (21 CFR 890.3920, Product Code KNN)

Legally marketed device compared for a determination of substantial equivalence:

The KISS seat is substantially equivalent to K942312; product code KNN; device name, Alden Lineage Wheelchair Cushion. Both devices are wheelchair seating components, regulation number 890.3920.

The reference device for the KISS seat is K982989; product code IOR: regulation number 890.3850; device name, Quickie suspension wheelchair series model XTR with the Rock Shox® monoshock suspension by Sunrise Medical. K982989 has physical characteristics that are substantially equivalent to the KISS device. Both devices support a person seated upright in a wheelchair. Both devices have a provision for suspension under the seat.

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The KISS back support is substantially equivalent to K923364; product code KNN; device name, Tilt Adjustable Back Recline Seating System by Labac Systems. Both devices are wheelchair seating components, regulation number 890.3920.

The reference device for the KISS back support is K123975; product code IOR; regulation number 890.3850; device name, Quickie and Zippie Series wheelchair with the Freestyle or Mono™ backrest by Sunrise Medical. K123975 has physical characteristics that are substantially equivalent to the KISS device. Both devices support a person seated upright in a wheelchair. Both devices have a provision for controlled movement of the back.

Device description:

Image /page/4/Figure/5 description: This image shows a KISS Seat and its components. The components are labeled with numbers 1 through 6, and include the seating platform (1), seat frame (2), pivot blocks (3), springs (4), drop hooks (5), and securing hardware (6). The image provides a detailed view of the seat's construction and the arrangement of its parts.

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Image /page/5/Figure/0 description: This image shows the KISS Back Support from a rear view. The image labels seven different parts of the back support, including the lumbar support (1), mounting brackets (2), upper back support (3), backrest (4), springs (5), mounting hardware (6), and upholstered cover (7). The image shows both a close up of the back support and how it looks attached to a wheelchair.

How the devices functions:

The KISS Seat assists upright seated posture by way of providing a solid seating platform with a dynamic seating interface that translates forces into motion. Springs under the seat respond to shifts in weight up and down and side to side. Movement is initiated at the hip and knee joints. The pelvis rotates and weight gets redistributed. KISS' solid seating platform eliminates the hammock effect of the standard cloth seat on a wheelchair. The springs provide suspension under the pelvis, where most of the user's weight is concentrated and absorb impact during wheelchair travel over bumps and thresholds.

Image /page/5/Figure/3 description: The image is a black and white drawing of a mechanical device. The device has a flat, rectangular base with several holes and springs visible. There are also several curved metal bars attached to the base, which appear to be part of the device's support structure. The drawing is detailed and technical in nature, suggesting it may be a blueprint or schematic.

The KISS seat responds to shifts in weight up and down and side to side.

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The KISS Back Support assists upright seated posture by way of providing a solid back support with a provision for movement of the upper back. The device is mounted to the wheelchair frame at the height, depth, and angle adjusted to the individual user. The lumber support is fixed in place and stabilizes the user in the seat. The upper back support moves about a horizontal axis in response to rearward force, relative to the lumbar support. Springs therebetween provide resilience and assist the user back to an upright seated position.

Image /page/6/Figure/1 description: The image is a black and white technical drawing of a piece of equipment. The equipment has a flat, rectangular back with several circular holes in it. The equipment is attached to two parallel bars that are connected to vertical supports on either side.

KISS' upper back support moves in response to rearward force. Springs assist the user back to an upright seated position.

Scientific concept for the KISS devices:

Investigations of sitting discomfort for individuals who sit for long periods of time have led to the development of ergonomic seating systems that enhance posture and comfort based on the premise that comfort is not achieved from a single, static position, but requires changes in posture through motion. The KISS devices are designed to translate forces generated by a wheelchair user's intentional or unintentional movement into motion. The intent is to allow, rather than block, the individual's specific movements. The devices are designed to absorb forces, which in turn initiates movement and disperses pressure in the wheelchair seat.

Significant physical and performance characteristics (Specifications):

The devices have a weight capacity of 250 LBS and fit manual wheelchairs 16" - 20" wide. The devices attach to tubular wheelchair frames 7/8" to 1-1/8" in diameter. The solid drop seat is designed to be used with a variety of wheelchair cushions. The back support is designed with a padded upholstered cover.

Specifications	KISS seat, model S1520	KISS back support, model B1620
Width	16-1/4" — 20-1/4"	16-1/4" – 20-1/4"
Height	4-1/8" — 5-5/8"	15-1/2"
Depth	16"	4-1/4"
Weight	1.78 LBS	8 LBS
Weight Capacity	250 LBS	250 LBS

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Image /page/7/Figure/0 description: The image shows a diagram of a KISS seat and back support with measurements. The KISS seat is 16 inches in height and 16-1/4 to 20-1/4 inches in width. The KISS back support is 15-1/2 inches in height and 4-1/4 inches in width, and the seat is 4-1/8 to 5-5/8 inches in height.

The KISS seat moves in response to shifts in weight up and down and side to side. Springs are positioned bilaterally under the pelvis, where most of the user's weight is concentrated. The springs provides up to 3/4" of suspension and up to 4° of rear displacement in the seat. Compression springs and low-friction plastic pivot blocks assist smooth dynamic motion. The drop hooks connect the KISS seat to the wheelchair frame. Two sets are included to position the seat height level with the seat rails on the wheelchair frame or with 1-1/2" of seat drop. Securing hardware locks the seating system in place. The seating platform is resin-infused recycled paper (Richlite®). The seat frame and drop hooks are made of aluminum with an anodized finish.

The KISS back support attaches to the upright canes (or push bars). The lumbar support is fixed in place and stabilizes the user in the seat. The upper back support flexes up to 30° with rearward force. Springs provide resilience and assist the user back to an upright seated position. The back support gets mounted to the wheelchair such that the horizontal pivot axis of the upper back support is ±7' from the top of the wheelchair seat rails. The mounting brackets adjust in width and are reversible for up to 4" of additional depth adjustment and up to 15° of overall angle adjustment. The upholstered cover fits over the back support assembly. The lumbar support, mounting brackets, and mounting hardware are anodized aluminum. The upper back support is powder-coated steel. The backrest is Richlite®. The upholstered cover is polyester. The padding is polyurethane foam encased in a layered lining comprised of polyester, fire barrier, and cotton fabric.

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KISS Dynamic Solid Drop Seat
PART	NAME	FUNCTION	MATERIAL
1	SEATINGPLATFORM	Provides solid postural support. For use with awheelchair cushion.	Richlite® (resin-infusedrecycled paper)
2	SEATFRAME	Rigid frame supports the seating platform andspring components. Adjusts in depth.	Aluminum withanodized finish
3	PIVOTBLOCKS	Connect the seating platform to the seat frame andpermits smooth dynamic movement of the seat.	Delrin® (low-frictionplastic)
4	SPRINGS	Spring assemblies connect to seat frame andseating platform. Provides up to 3/4" of seatsuspension with up to 4° of rear displacement.	Compression springs,plastic, rubber
5	DROPHOOKS	Connects the KISS seat frame to the wheelchairframe. Adjusts to wheelchairs 16" to 20" wide.Positions seat height relative to the seat rails of thewheelchair frame: level or with 1-1/2" of seat drop.	Aluminum withanodized finish
6	SECURINGHARDWARE	Locks KISS seat assembly to the wheelchair frame(supplied by third-party vendors).	AEL VERSAlock® orBodypoint Clickit®(plastic & steel)

KISS Dynamic Back Support

PART	NAME	FUNCTION	MATERIAL
1	LUMBAR SUPPORT	Provides lower back support. Stabilizes the user in the seat.	Aluminum with anodized finish
2	MOUNTING BRACKETS	Adjusts to the wheelchair width. Provides up to 4" of additional depth and up to 15° of overall angle adjustment.	Aluminum with anodized finish
3	UPPER BACK SUPPORT	Moves with rearward force. Flexes up to 30° rearward.	Steel with powder-coated finish
4	BACKREST	Attaches to the upper back support. Provides solid postural support.	Richlite® (resin-infused recycled paper)
5	SPRINGS	Provide resilience to the upper back support. Assists the user back to an upright position.	Spring steel
6	MOUNTING HARDWARE	Secures the back support to the wheelchair. Fits tubular frames 7/8" to 1-1/8" in diameter.	Aluminum with anodized finish
7	UPHOLSTERED COVER	Pads and protects the user from the solid surfaces and moving parts. Cover is removable and washable. Padded inserts are removable.	Polyester, Tek Fire Barrier, and cotton fabric with Polyurethane foam padding

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Intended use:

The KISS devices are wheelchair components intended for medical purposes that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part. The KISS devices are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seating platform or back support with dynamic motion.

Comparison of indication statement:

The predicate devices' product code is KNN, classification 890.3920, wheelchair component. The Jay Basic Back and the Jay Adjustable Solid Seat by Sunrise Medical are solid postural supports for a person seated in a wheelchair. These devices are intended for posture and positioning in a wheelchair and are 510(k) exempt.

The reference devices' product code is IOR, classification 890.3850, mechanical wheelchair. K982989 and K123975 are Sunrise Medical's Quickie and Zippie series wheelchairs with provisions for suspension in the seat and controlled movement of the back. These devices are intended for individuals limited to a sitting position.

The KISS devices are solid postural supports for a wheelchair with provisions for movement of the seat and back support. The devices are intended for posture and positioning for a person seated in a wheelchair. The differences are not critical to the intended therapeutic use because the KISS devices do not alter the safety and effectiveness of the device when used as labeled.

Comparison of technological characteristics of the KISS devices to the reference devices:

The K982989 suspension series wheelchair and the KISS seat are similar in technological characteristics. Both devices provide suspension for a person seated in a wheelchair. The reference device is a wheelchair with suspension located under the wheelchair seat that provides up to 2.5" of rear wheel displacement. The KISS device is a wheelchair seat with suspension that provides up to 3/4" of rear seat displacement.

The K123975 Quickie & Zippie series wheelchair and the KISS back support are similar in technological characteristics. Both devices have solid back supports that move with rearward force. The predicate device is a wheelchair with a back support system. The KISS device is a back support system for a wheelchair. The Ouickie Freestyle backrest system piyots about a horizontal axis at the middle of the backrest. The Quickie Mono™ backrest pivots about a horizontal axis at the base of the back. Elastomer springs on the Mono™ backrest assist the wheelchair user back to an upright seated position. The Quickie back support systems are modifications the Quickie series wheelchair. The KISS back support is a modification to a wheelchair because it replaces the standard cloth backrest on the wheelchair.

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Device Comparison Table:

Description	KISS seat	Reference Device K982989
Indications for Use	For posture and positioning	To provide mobility to persons limitedto a sitting position
Prescription / over-the-counter use	Prescription & Over-the-counter	Prescription & Over-the-counter
Size	Fits wheelchairs 16" – 20"	Wheelchair sizes 14" – 20"
Seat height	Level with wheelchair seat rails; with 1-1/2"seat drop option	Level with wheelchair seat rails withwheelchair frame adjustments
Design	Device consists of a seat frame and a solidseating platform with suspensiontherebetween. Seating system attaches towheelchair frame with drop hooks andsecuring hardware.	Device is a suspension serieswheelchair with a standard cloth seat.The Rock Shox® monoshocksuspension is located under the seatand integrated with wheelchairframe.
Suspension	Compression spring assemblies locatedbetween the seat frame the solid seatingplatform responds to shifts in weight upand down and side to side. The deviceprovides up to .75" of suspension with upto 4° of rear displacement in the seat.	The Rock Shox® assembly is mountedunder the wheelchair seat andintegrated with the wheelchair frame.The system provides shock absorptionwith up to 2.5" of rear wheel travel inresponse to uneven terrain.
Attachment towheelchair	Suspension is integrated in seat assemblythat attaches to wheelchair frame withdrop hooks & securing hardware.	Suspension is integrated withwheelchair frame.
Seat Cushion	For use with a wheelchair cushion	For use with a wheelchair cushion
Weight capacity	250 lbs.	250 lbs.

Description	KISS back support	Reference Device K123975
Indications for Use	For posture andpositioning	To provide mobility to persons limited to a sittingposition
Prescription/over-thecounter use	Prescription & Over-thecounter	Prescription & Over-the-counter
Size	Fits wheelchair sizes 16" –20"	Wheelchair sizes:Quickie IRIS: 14" – 22"Quickie 7: 12" – 20"
Height of Back Support	Mid back	Quickie IRIS: Shoulder heightQuickie 7: Mid back

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Design	Device consists of a lumbarsupport and an upper backsupport with springs therebetween. The lumbarsupport gets fixed to thewheelchair and stabilizesthe user in the seat.	Quickie IRIS: Mono™ Backrest replaces the standardback rest on the wheelchair frame and provides solidpostural support that moves with resilience.Quickie 7: Freestyle Backrest System is integrated withthe wheelchair frame to provide solid mid-height backsupport that moves.
Movement	Upper back support movesrelative to lower lumbarsupport about a transvershorizontal axis.	Quickie IRIS: Full-length Mono™ Backrest (withdynamic option) moves about a horizontal axis at thebase of the back support system.Quickie 7: Freestyle Backrest System moves about ahorizontal axis at the middle of the backrest.
Dynamic component	Two spring steelassemblies mountedbetween lumbar supportand upper back support	Quickie IRIS: Two elastomer spring assemblies areintegrated in mounting bracket of the Mono™Backrest.Quickie 7: Freestyle Backrest System moves freelywithout springs
Wheelchair attachment	Attaches to a standardmanual wheelchair frame	Mono™ Backrest attaches to Quickie IRIS wheelchairwith a modification to the frame.Freestyle Backrest System is integrated with amodified frame for the Quickie 7 wheelchair.
Weight capacity	250 lbs	250 lbs / 350 lbs (Heavy Duty)

Assessment of performance data - Non-clinical data:

The KISS devices passed ISO 16840-3 Wheelchair seating – Part 3: Determination of static, impact and repetitive load strengths for postural support devices.

The KISS devices were installed on a Quickie series wheelchair and tested according to RESNA WC-1, Sections 1, 5 & 7 for static stability, maneuverability, dimensions, and seating measurements. Wheelchair stability with the KISS seat was increased on the rearward incline with the wheels locked and decreased on the rearward (wheels unlocked), forward and lateral inclines. Wheelchair stability with the KISS back support was increased on rearward inclines and decreased on forward and lateral inclines. Maneuverability, dimensions, and measurements were not changed.

ISO 898-7 was applied to test the durability of the clamping system and mechanical fasteners to hold the KISS seat in place. Selected securing hardware intended to be used with the KISS device was tested and passed.

Loaded Deflection was tested to determine the most effective position for placement of the springs under the KISS seat. The results indicate that the springs should be positioned under the pelvis and not exceed one adjustment position (1") to either side of this position.

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A customized bench test to determine The Influence of the KiSS dynamic seat on a Wheelchair Cushion's Force-Deflection relationship was conducted to address FDA concerns with prior submission K120940 regarding off-loading from the wheelchair cushion when used with the KISS seat. The results indicate that the user should lift an additional 0.4" to fully offload from the wheelchair cushion.

The KISS seat was tested for Wheelchair Compatibility on an assortment of wheelchairs. The purpose was to identify restrictions and measure clearances needed to install the KISS seat on a wheelchair frame. The KISS seat fit the standard folding manual wheelchairs and not the ultralight models because of the design of the rigid frame.

Lab test results for ISO 10993-10: Biological evaluation of medical devices - Part 10 indicate biocompatibility for cytotoxicity, skin irritation and sensitization for the KISS back support upholstered cover. The upholstered cover was tested for resistance to ignition according to ISO 16840-10. Test #1 passed; Test #2 failed due to the sample continuing to emit visible smoke for 30 seconds after removal of the heater cartridge. The standard currently only allows 20 seconds, therefore the specimen did not pass the criteria after the initial test was performed.

Conclusion:

The performance report data indicate that the KISS devices installed on a wheelchair is as safe, as effective, and performs as well as the predicate and reference devices K982989 and K123975. The devices passed ISO and RESNA bench test standards. Clinical testing indicates the technology does not negatively affect interface pressure and has reduced peak interface pressures measured during propulsion. However, dynamic seating may reduce wheelchair stability, therefore, contraindications as noted in the proposed labeling must be observed.

Regulation Number and Section

§ 890.3920 Wheelchair component.

(a)
Identification. A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.