TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).

· TC-1018. for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in).

TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.

· TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).

TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / cloas in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.

TC-0608, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl . Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).

Device Description

The Proposed Device, the TubeClear Control Box and Clearing Stem, is comprised of Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube), while the Tube remains in the Patient, and directs the Clearing Stem's progression along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion and restores Tube patency.

Three (3) new Clearing Stem Models are proposed. The additional Clearing Stem Models expand the specific indications for use.

AI/ML Overview

This document describes the TubeClear Control Box and Clearing Stem (referred to as the "Proposed Device") and its substantial equivalence to a previously marketed device, also called TubeClear (referred to as the "Predicate Device"). This is a summary from a 510(k) premarket notification to the FDA. The information provided focuses on the non-clinical performance data to demonstrate substantial equivalence, as no clinical data was collected.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria and reported device performance. Instead, it uses qualitative statements about conformance and substantial equivalence.

Acceptance Criteria Category	Reported Device Performance (Proposed Device)
Technical Testing
Product Specifications	Met all product specifications.
Wire Tip Flexibility	Assessed, results contribute to substantial equivalence.
Forces on Clearing Stem	Assessed, results contribute to substantial equivalence.
Distal Wire Pull Force	Assessed, results contribute to substantial equivalence.
Accelerated Shelf Life	Met all acceptance criteria for 12 months storage. Ongoing testing for longer shelf life.
Packaging Integrity / Transportation Vibration	Met all acceptance criteria for US highway truck.
Efficacy Testing
Human Factors Validation	Successfully completed by certified and licensed healthcare practitioners. Results support substantial equivalence of effectiveness.
Device Effectiveness	Effectiveness during simulated use was compared to Predicate Device; results support substantial equivalence.
Safety Testing
Tube Integrity (scratches, nicks, tears, abrasions, punctures)	Assessed; found to be substantially equivalent to Predicate Device.
Tube Heating	Found to be negligible and substantially equivalent to Predicate Device.
Tube Movement	Found to be substantially equivalent to Predicate Device.
General Medical Electrical Equipment Safety (IEC-60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007))	Conformance tested and found by third party (Intertek Group).
Usability Engineering (IEC 60601-1-6: 2010, IEC 62366: 2007)	Conformance tested and found by third party (Intertek Group).
Risk Management (ISO 14971-compliant system)	Conformance tested and found by third party (Intertek Group).
Electromagnetic Compatibility (IEC 60601-1-2:2001 +A1:2004)	Conformance tested and found by third party (Intertek Group).
Intestinal Lining Puncture (Animal Testing - worst case over-insertion)	Results support that the Proposed Clearing Stem Design is safe for its intended use and substantially equivalent to the Predicate Device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Technical Testing: Not explicitly stated for each test, but implied to be sufficient for verification and adherence to product specifications (e.g., "Verification confirmed that the Clearing Stem Models met product specifications").
- Efficacy Testing (Human Factors Validation & Device Effectiveness): The number of participants for human factors validation is not specified, but they are described as "certified and licensed healthcare practitioners." The number of simulated uses or cases for device effectiveness testing is also not explicitly stated.
- Safety Testing: Not explicitly stated for each test (e.g., number of tubes tested for integrity, heating, or movement).
- Animal Testing: Not explicitly stated, but performed "on porcine jejunum tissue."
Data Provenance: The document does not specify the country of origin of the data. It indicates the testing was "in-house" for much of the technical, efficacy, and safety testing, with some safety tests conducted by a "third-party organization (Intertek Group (Boxborough, MA))" in the US.
Retrospective or Prospective: All testing described appears to be prospective as it's designed to evaluate the new device for market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Human Factors Validation: "Certified or Licensed Healthcare Practitioners" were involved. The specific number or their detailed qualifications (e.g., years of experience, specific specialty) are not provided. They were the "users" in this context, and their performance likely contributed to the "ground truth" of usability.
Other Testing: For the bench and animal testing, the "ground truth" was established by objective measurements and assessments against predefined criteria, rather than expert consensus on interpretation. For instance, "Verification confirmed that the Clearing Stem Models met product specifications," implies internal testing against engineering specifications forming the ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the context of expert review, as the testing primarily involves objective performance metrics and human factors validation rather than interpretive tasks.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a mechanical tool for clearing clogs, not an AI-assisted diagnostic or interpretive system. The "Human Factors Validation and comparison of device effectiveness testing" focused on the performance of the device itself and user interaction, not on improving human "reading" or diagnostic skills with AI.

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

This question is not applicable to the TubeClear system, as it is a mechanical device that inherently requires "human-in-the-loop" operation (an operator manually inserts and directs the clearing stem). There is no "algorithm only" component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for evaluating the TubeClear device was primarily based on:

Engineering Specifications/Objective Measurements: For technical aspects like product specifications, wire tip flexibility, forces, shelf life, and packaging.
Simulated Use Performance: For efficacy, where the ability to clear occlusions in simulated tubes was measured.
Direct Observation/Measurement of Physical Effects: For safety, assessing tube integrity, heating, and movement directly.
Controlled Animal Study: For assessing the risk of puncture in worst-case scenarios.
Conformance to Consensus Standards: For basic safety, usability engineering, risk management, and electromagnetic compatibility.

8. The sample size for the training set

This question is not applicable as the TubeClear device is a mechanical device and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads in profile, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 30, 2016

Actuated Medical, Inc. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K163092

Trade/Device Name: TubeClear Control Box and Clearing Stem Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: November 2, 2016 Received: November 4, 2016

Dear Dave Yungvirt,

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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K163092

Device Name TubeClear Control Box and Clearing Stem

Indications for Use (Describe)

· TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).

TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.

· TC-0608. for Nasoenteral and Nasogastric Tubes composed of Polyviny) Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).

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 Actuated Medical. The logo consists of the words "ACTUATED" in gray and "MEDICAL" in orange, with a stylized orange cross to the left of the word "ACTUATED". Below the logo is the tagline "Innovative motion + Positive outcomes" in gray.

310 Rolling Ridge Drive Bellefonte, PA 16823 + p (814) 355.0003 + f (814) 355.1532 ActuatedMedical.com

Operating As ...

- ISO 13485:2003 Certified
- ISO 14971:2007 Compliant
- Women-Owned Certified

SECTION 5: 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92

510(k) Number:

5.1: Applicant Information

Date Prepared:	November 30, 2016
Name and Address:	Actuated Medical, Inc.310 Rolling Ridge DriveBellefonte, PA 16823Ph: (814) 355-0003Fx: (814) 355-1523
Contact Person:	Katherine M. ErdleyDirector Quality AssurancePh: (814) 355-0003 x116Fx: (814) 355-1523Email: Katherine.Erdley@actuatedmedical.com

5.2: Device Information

Classification:	KNT
Trade Name	TubeClear Control Box and Clearing Stem
Common Name:	In Patient Tube Clearing System
Classification Name:	Tube, Gastrointestinal and Accessories,21 C.F.R. §876.5980
Control Box Model:	101
Clearing Stem Models:	TC-0608, TC-0812, and TC-1018

Image /page/3/Picture/13 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange, transitioning from a lighter shade to a darker one. A pattern of squares in alternating shades of orange creates a checkerboard effect. A wavy line in a lighter shade of orange meanders across the image, adding a sense of movement and fluidity to the composition.

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Image /page/4/Picture/1 description: The image is a close-up of an orange background with a pattern of lighter orange squares. The squares are arranged in a staggered pattern, creating a visually interesting texture. A wavy line runs across the squares. The overall effect is a warm and inviting design.

5.3: Predicate Device

The legally marketed device to which substantial equivalence is being claimed:

510(k) Number	Trade Name	Manufacturer
K131052	TubeClear	Actuated Medical, Inc.

The Predicate Device, TubeClear, is comprised of Control Box Model 101 and Clearing Stem Models NE-1036, NE-1042, NE-1043, NE-1045, NE-1048, NE-1050, NE-1055, G-1008, G-1009, G-1010, G-1011, G-1012, and G-1014.

5.4: Device Description

Three (3) new Clearing Stem Models are proposed. The additional Clearing Stem Models expand the specific indications for use.

5.5 Intended Use

The Proposed Clearing Stem Models are substantially equivalent to the Predicate Clearing Stem Models in regards to intended use and therapeutic The intended use is to clear occlusions/clogs from feeding and effect. decompression tubes (i.e., Tubes). For both the Proposed and Predicate Clearing Stem Models, the therapeutic effect is to restore Tube patency and alleviate the need for Tube replacement.

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Image /page/5/Picture/1 description: The image is an abstract design featuring a gradient of orange hues. The left side of the image is a solid, darker shade of orange, which gradually transitions into a lighter, patterned area on the right. This patterned area consists of a grid-like arrangement of squares in alternating shades of orange, creating a checkerboard effect. Overlaying this grid is a series of wavy lines in a lighter orange, adding a dynamic and flowing element to the geometric background.

Both the Proposed and Predicate Clearing Stem Models are disposable, single use devices. The Proposed Clearing Stem Models are intended for use by Certified or Licensed Healthcare Practitioners. The Predicate Clearing Stem Models are intended for use by Licensed Healthcare Practitioners. Human Factors Validation testing results support substantial equivalence of the expanded User group.

Both the Proposed and Predicate Clearing Stem Models are intended for use at the Patient's bedside location (e.g., hospital, non-acute care facility, Patient's home). The intended use locations support substantially equivalence of the use environment.

Both the Proposed and Predicate Clearing Stem Models enter a Tube that is within the Patient, no Model makes direct contact with the Patient. Both the Proposed and Predicate Clearing Stem Models are placed in a Tube that is in the Patient's gastrointestinal (GI) system. Both the Proposed and Predicate Clearing Stem Models do not require sterile conditions for their intended purpose.

5.6 Indications for Use

5.6.1: Specific Indications for Use of the Proposed Clearing Stem Models

. TC-1018. for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in).
TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
. TC-0812. for Nasoenteral and Nasoqastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).
Image /page/5/Picture/11 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange, transitioning from a solid color to a pattern of squares. A wavy line meanders across the image, adding a dynamic and fluid contrast to the structured background.

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Image /page/6/Picture/1 description: The image is a background with a pattern of orange squares and squiggly lines. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The squiggly lines are a lighter shade of orange and run diagonally across the squares. The background is mostly orange, with a small white strip at the bottom.

TC-0608, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl . Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).

5.6.2: Specific Indications for Use of the Predicate Clearing Stem Models

TubeClear is indicated for use ONLY and SOLELY in clearing occlusions / clogs in Feeding and Decompression Tubes in adult patients that have a Tube of size 10 to 18 Fr.

The Clearing Stem Models are indicated for use as follows:

NE-1036, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 91 cm (36 in).

NE-1042, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 107 cm (42 in).

NE-1043, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 109 cm (43 in).

NE-1045, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 114 cm (45 in).

NE-1048, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 122 cm (48 in).

NE-1050, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 127 cm (50 in).

NE-1055, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 140 cm (55 in).

G-1008, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 20 cm (8 in).

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G-1009, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 23 cm (9 in).

G-1010, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 25 cm (10 in).

G-1011, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 28 cm (11 in).

G-1012, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 30 cm (12 in).

G-1014, for Gastrostomy and Jejunostomy Tubes that are of size 10- 18 Fr and have a length of 36 cm (14 in).

The specific indications for use vary from Clearing Stem Model to Clearing Stem Model; however, the differences are not critical to the intended therapeutic use of the device, which is restoring patency to the Tube and alleviating the need for Tube replacement. The differences do not affect the safety and effectiveness of the Proposed Clearing Stem Models.

5.7: Technological Characteristics

The technological characteristics of the Proposed Device are similar to the Predicate Device. Both the Proposed and Predicate Devices have the same operating principle (i.e., Operator interaction with the Device and the Clearing Stem Wire mode of actuation). Both the Proposed and Predicate Clearing Stem Models are manually inserted and advanced into the Patient's Tube. Both the Proposed and Predicate Clearing Stem Models physically interact with the occlusion material inside a Tube. Both the Proposed and Predicate Clearing Stem Models mechanically clear occlusions restoring Tube patency.

The design features of the Proposed Device are similar to the Predicate Device. Both the Proposed and Predicate Clearing Stem Models are single use. Both the Proposed and Predicate Clearing Stem Models have rounded and flexible Wire Tips. Both the Proposed and Predicate Clearing Stems have multiple Models differentiated by color. Both the Proposed and Predicate Clearing Stem Models have informative labeling. Both the Proposed and Predicate Clearing Stem

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Models have a depth limiting component that determines the Working Length (i.e., the length of the Clearing Stem that can be inserted into the Tube).

The method of attachment of the depth limiting component is different between the Proposed and Predicate Devices. The Proposed Device depth limiting component (i.e., Depth Limiter) is attached to the Clearing Stem Model by the Operator. The Predicate Device depth limiting component (i.e., Collar) is attached to the Clearing Stem Model by the Manufacturer.

Performance data and Human Factors Validation testing results support substantial equivalence of the technological characteristics of the Proposed and Predicate Devices.

5.8: Non-Clinical Performance Data

As the same Control Box (i.e., Model 101) is used with the Proposed and Predicate Clearing Stem Models, testing presented in this submission focused predominantly on the Clearing Stem. Bench Testing of the Clearing Stem focused in three areas: Technical, Efficacy, and Safety. Technical testing included verification of product specifications, Wire tip flexibility, forces on Clearing Stem, distal Wire pull force, accelerated shelf life, and packaging integrity / transportation vibration. Efficacy testing included Human Factors Validation and comparison of device effectiveness. Safety testing evaluated the potential for Tube damage (i.e., Tube Heating and Integrity), Tube movement during use of TubeClear, and Operator error coupled with abnormal use.

5.8.1: Technical Testing

Verification confirmed that the Clearing Stem Models met product specifications and all acceptance criteria. Transportation vibration testing met all acceptance criteria for US highway truck. Shelf life was tested via accelerated shelf life testing and met all acceptance criteria for 12 month storage. Additional testing for longer shelf life is ongoing.

5.8.2: Efficacy Testing

Human Factors Validation testing by certified and licensed healthcare practitioners was successfully completed. Evaluation of effectiveness during

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Image /page/9/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange hues, with the left side being a solid, darker shade that gradually transitions to a lighter, patterned area on the right. The pattern consists of a grid-like arrangement of squares or rectangles in alternating shades of orange, creating a checkerboard effect. Overlaying this geometric pattern are wavy lines in a lighter orange, adding a sense of movement and fluidity to the composition.

simulated use was performed for the Proposed Clearing Stem Models and compared to the effectiveness of the Predicate Clearing Stem Models.

Human Factors Validation and comparison of device effectiveness testing results support substantial equivalence of effectiveness of the Proposed and Predicate Devices.

5.8.3: Safety Testing

Safety testing for the Proposed and Predicate Clearing Stem Models included an assessment of Tube Integrity, Tube Heating, and Tube movement. Appropriate safety tests were determined using AMI's ISO 14971-compliant system's risk management activities. Effect of Clearing Stem on Tube Integrity (e.g., scratches, nicks, tears, abrasions, punctures to the inner tube surface) was found to be substantially equivalent for both Devices use of TubeClear. Tube heating was found to be negligible and substantially equivalent for both Devices during use of TubeClear. Tube movement was found to be substantially equivalent for both Devices during use of TubeClear.

A third-party organization (Intertek Group (Boxborough, MA)) tested and found conformance to general requirements for basic safety and essential performance for medical electrical equipment, application of usability engineering, and ISO 14971 risk management framework as per consensus standards IEC-60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-1-6: 2010, and IEC 62366: 2007. The third-party organization also tested and found Electromagnetic Compatibility conformance as per consensus standard IEC 60601-1-2:2001 +A1:2004.

Safety testing results support substantial equivalence of safety of the Proposed and Predicate Devices.

5.8.4 Animal Testing

Animal testing was carried out to assess the probability that the Proposed Clearing Stem Models would puncture the intestinal lining of the patient in the event that the Clearing Stem is over-inserted into the tube. Forces generated by the worst case scenario (Depth Limiter set so Working Length is longer than Tube length) coupled with abnormal use (excessive force) on porcine jejunum tissue were analyzed on a force gauge to determine a reasonable assurance of

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Image /page/10/Picture/1 description: The image is an abstract design featuring shades of orange. The background consists of a pattern of squares in alternating shades of orange, creating a textured effect. Overlaying this pattern are wavy lines, also in a lighter shade of orange, adding a dynamic element to the composition.

safety. Animal Testing results support that the Proposed Clearing Stem Design is safe for its intended use in adult patient populations and substantially equivalent to the Predicate Clearing Stem Design in terms of safety if Operator Error Coupled with Abnormal Use were to occur.

5.9: Clinical Performance Data

No clinical data was collected; therefore, no clinical data is presented in this submission.

5.10: Conclusions

The scientific data demonstrates that the Proposed Clearing Stem Models are substantially equivalent to the Predicate Clearing Stem Models. The 510(k) Substantial Equivalence Decision Making Process Flow Chart was used by Actuated Medical, Inc. to determine Substantial Equivalence.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.