AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.

Device Description

The EMED AccuSert Needle Inserter is a manually operated, reusable, spring-loaded injection device. This device is used to insert EMED subcutaneous infusion administration sets. The device is contraindicated for use with other sets. The AccuSert Needle Inserter consists of a plastic body containing a stainless-steel spring and a needle carrier component.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the AccuSert Needle Inserter. However, it does not contain the detailed acceptance criteria and study results typically found in the clinical study section of a 510(k) submission for a device that involved an AI/ML component or complex efficacy claims.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Sil-Serter Inserter (K010377). This typically involves comparing technological characteristics, intended use, and performance without necessarily requiring extensive human-in-the-loop or standalone AI performance studies.

Here's a breakdown based on the information provided and what is missing:

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

Acceptance Criteria Mentioned (Implicitly or Explicitly):
- Cocking Force: 9-7 lbf (AccuSert) vs. Less than 7 lbf (Predicate). Note: The range for AccuSert (9-7) seems unusual, usually it's a min-max or a single value/range. This could be a typo in the document.
- Trigger/Release Force: Less than 7 lbf (AccuSert) vs. Less than 7 lbf (Predicate).
- Insertion Force: 1.0-2.5 lbf (AccuSert) vs. 1.67 lbf (Predicate).
- Life Cycle: Designed to withstand 550 cycles (AccuSert) vs. 600 cycles (Predicate).
- Biocompatibility: Meet ISO 10993 standards (Chemical Characterization, Cytotoxicity, Sensitization, Skin Irritation).
- Usability: Intended users could use the device safely and effectively without user errors or difficulties that could cause harm.
- Mechanical Integrity/Functionality: Retains mechanical properties and functions, passes visual/functional tests, chemical resistance, and drop test.
Reported Device Performance:
- Cocking Force: "9-7 lbf" (AccuSert). The document states "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
- Trigger/Release Force: "Less than 7 lbf" (AccuSert).
- Insertion Force: "1.0 -2.5 lbf" (AccuSert). The document states "AccuSert was designed with adequate force to insert the intended needle sets with the minimum force and impact to the patient skin as confirmed by conducted performance testing."
- Life Cycle: "Designed to withstand 550 cycles" (AccuSert). The text states: "The number of simulated uses for the AccuSert Needle Inserter includes data derived from testing of multiple Inserters as well as performance testing to validate expected usable life duration."
- Biocompatibility: "AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation." (Passed all listed tests).
- Usability: "The conducted Human Factors Validation Testing serve as objective evidence that the instructions for use provide the user with sufficient information to understand how the device is used." It also states for Cocking Force and Trigger/Release Force that "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
- Mechanical Integrity/Functionality: "Results from performance testing indicate that the product meets the established performance requirements." (Implies passing visual/functional, chemical resistance, and drop tests).

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: Not explicitly stated for performance tests (e.g., how many devices were subjected to life cycle testing, drop tests, etc.). For usability/human factors, the sample size is also not specified.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/engineering tests ("Design Verification," "Biocompatibility," "Usability Evaluation").
Retrospective or Prospective: These appear to be prospective design verification and validation tests, not historical data analyses.

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)

Not Applicable / Not Provided: This question is highly relevant for AI/ML devices where expert interpretations form ground truth. For a mechanical device like a needle inserter, ground truth is established through physical measurements, engineering standards, and usability testing with representative users, rather than expert interpretation of medical images or conditions. The document mentions "Human Factors Validation Testing" and "Usability Validation" with "intended users" but does not specify the number or qualifications of experts establishing ground truth in the way this question implies. Ground truth here relates to meeting pre-defined physical and usability specifications.

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

Not Applicable / Not Provided: Adjudication is typically used in clinical studies or expert review processes to resolve discrepancies in diagnoses or interpretations for AI/ML ground truth generation. For direct performance testing of a mechanical device, results are typically objective measurements against specified criteria. Usability studies have methods for assessing user errors and difficulties, but "adjudication" in the sense of reconciling conflicting expert opinions is not described.

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

No: The document explicitly states: "No clinical study is included in this submission." An MRMC study is a type of clinical study, specifically for diagnostic devices (often AI-assisted). This device is a mechanical inserter, not a diagnostic tool, and its 510(k) submission relied on non-clinical performance and substantial equivalence.

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

Not Applicable: This is a mechanical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The device's "standalone" performance is its mechanical performance (cocking force, insertion force, life cycle, etc.), which was tested as described under "Design Verification."

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

Engineering Specifications and Usability Objectives: For this device, ground truth is defined by:
- Pre-defined engineering specifications (e.g., target force ranges, number of cycles).
- Biocompatibility standards (ISO 10993).
- Human Factors/Usability standards (ANSI/AAMI HE75, IEC 62366-1) which define what constitutes safe and effective user interaction and freedom from critical errors.
- Physical performance standards (ISO 28620 for drop test).
- The "truth" is whether the device performs within these acceptable parameters during testing.

8. The sample size for the training set

Not Applicable: This is a mechanical device, not an AI/ML model that requires training data.

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

Not Applicable: See point 8.

Summary

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October 20, 2022

Emed Technologies Corporation Olena Whalen QA/RA/CA Manager 1262 Hawks Flight Ct. Ste. 200 El Dorado Hills, California 95762

Re: K213429

Trade/Device Name: AccuSert Needle Inserter Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: Class II Product Code: KZH Dated: September 6, 2022 Received: September 13, 2022

Dear Olena Whalen:

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 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

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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 mediation-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,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213429

Device Name AccuSert Needle Inserter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K213429 510(k) Summary

Date Prepared: October 20, 2022

I. SUBMITTER

EMED Technologies Corporation 1262 Hawks Flight Ct El Dorado Hills, CA 95762

Contact Person: Olena Whalen Contact Person Title: OA/RA/CA Manager Tel: 916.932.0071 ext. 114 Fax: 916.932.0074 Email: owhalen@emedtc.com

II. DEVICE

Trade Name: AccuSert Needle Inserter Common or Usual Name: Introducer, Syringe Needle Classification Name: Syringe needle introducer Regulation Number: 21 CFR §880.6920 Product Code: KZH

III. PREDICATE DEVICE

(K010377), Sil-Serter Inserter (Product Code - KZH)

IV. DEVICE DESCRIPTION

The user places and securely seats the infusion set onto the carrier. The administration set is then loaded and locked into the AccuSert by pushing the needle carrier handle (thereby compressing the internal spring) until the carrier clicks/locks into place. The AccuSert is placed in contact with the intended insertion site and activated to release the infusion set at a 90° angle. The spring drives the carrier and the infusion set needle is inserted into the users' subcutaneous tissue.

V. INTENDED USE/INDICATIONS FOR USE:

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VI. TECHNOLOGICAL COMPARISON WITH PREDICATE DEVICE

The AccuSert Needle Inserter is not based on new technology, nor is it based on new clinical application of an existing technology. The device is based on well-established technology that has existed for decades; any advances or improvements are the result of incremental change of the existing technology in which design enhancements were enacted in an effort to improve safety, appearance, and usability, as well as to allow for physical compatibility with proprietary EMED administration set design characteristics and performance requirements.

Parameter	Sil-Serter Inserter(K010377)	EMED Accusert NeedleInserter	Comparison
Indications forUse	The Silserter infusion setinsertion system is intendedas an aid for insertion of theSilhouette family of infusionsets.Single patient use only.	AccuSert Needle Inserter isintended for use at home orhospital environment to assistinserting EMED subcutaneousadministration needle sets intothe subcutaneous tissue at90 degrees.Single patient use only.	Insignificant difference (SeeNOTE 1 below).
Prescription orOver theCounter	Prescription	Prescription	SAME
Environment ofUse	Home use	Home and Hospital Use	Insignificant difference (seeNOTE 2 below)
Material(s)	Housing: ABS PlasticCarrier: NylonBarrel: ABS PlasticSprings: 302 Stainless SteelRelease buttons: NylonDamper ring: ThermoplasticElastomer (TPE)Trigger button:PolycarbonateBonding Solvent:Cyclohexanone	Housing: PolycarbonateNeedle Carrier: DelrinSprings: 304 Stainless SteelRelease button: ABS Plastic	Insignificant difference (seeNOTE 3 below)
Dimensions(l x h x d) andWeight	Approximately6.75in x 1.43in x 1.43inWeight not specified.	1.65in x 1.41in x 4.03in36.6 grams (0.08 lbs.)	Insignificant difference (seeNOTE 4 below)
Principle ofAction	Manually Operated	Manually Operated	SAME
Pressure Source	Spring-loaded	Spring-loaded	SAME
SafetyFeature(s)	Device release button lockingmechanism to preventaccidental discharge. Carriertabs to maintain travelingdistance of 1.69in. andinsertion distance.	Recessed released buttonmechanism to prevent accidentaldischarge. Carrier stop tomaintain traveling distance of1.19in.	Insignificant difference (seeNOTE 5 below)
DevicePerformance	Designed to withstand 600cycles	Designed to withstand 550cycles	Insignificant difference (seeNOTE 6 below)
Cocking Force	Less than 7 lbf	9-7 lbf	Insignificant difference (seeNOTE 7 below)
Trigger/ReleaseForce	Less than 7 lbf	Less than 7 lbf	SAME

Table 5-1: Comparison of Technological Characteristics with Predicates

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Parameter	Sil-Serter Inserter(K010377)	EMED Accusert NeedleInserter	Comparison
Insertion Force	1.67 lbf	1.0 -2.5 lbf	Insignificant difference (seeNOTE 8 below)
Biocompatibility	Not applicable. The devicedoes not come into directcontact with blood or bodyfluids. Momentary limitedskin contact.	The battery of testing included:• Chemical Characterization• Cytotoxicity• Sensitization• Skin Irritation	Insignificant difference (seeNOTE 9 below)
Sterility	Non-Sterile	Non-Sterile	SAME
ValidatedCleaningMethod	Manual	Manual	SAME
Usable Life	1 year	1 year	SAME

NOTE 1: The Indications for Use statement for the AccuSert Needle Inserter are not identical to the predicate device. However, the differences do not affect the intended use of the device, nor does it affect the safety and effectiveness of the device relative to the predicate. Both devices are intended to aid in the insertion of specific infusion sets. Both the predicate and subject AccuSert Needle Inserter are indicated for single patient, multi-use. The insertion of the needle into subcutaneous tissue at 90 degrees is achieved through the design of the needle of the infusion set and not the design of the AccuSert Needle Inserter.

NOTE 2: The use of AccuSert Needle Inserter in the hospital or home environment does not have any impact on the safety or effectiveness of the device as there is no special training needed to use the device. The conducted Human Factors Validation Testing serve as objective evidence that the instructions for use provide the user with sufficient information to understand how the device is used.

NOTE 3: There are no bonding solvents or glues used in AccuSert Needle Inserter. The materials that compose the AccuSert Inserter were identified for their durability and performance characteristics. The plastics selected are widely used for medical device applications. The slight differences in the materials do not raise any new safety or effectiveness questions. The performance testing (biocompatibility and design verification) conducted on AccuSert Needle Inserter demonstrates the device functions as intended.

NOTE 4: The devices' form factor is different in design for the specific needle sets. The size and/or weight difference does not impact portability, usability, safety or the intended function, as both devices can insert the corresponding needle set into the skin.

NOTE 5: Both devices are designed to prevent accidental discharge. The minor difference in traveling distance do not have an impact to safety, performance, or effectiveness as both devices were designed and tested to insert the specific infusion needle sets into the skin. The AccuSert was designed with an adequate traveling distance to insert the intended needle set while maintaining small form factor design.

NOTE 6: The specified usable life for the AccuSert Needle Inserter and predicate are very similar: 550 cycles and 600 cycles, respectively. This is a minor difference that does not indicate any reasonable difference in technology, performance, or safety of the devices. The number of

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simulated uses for the AccuSert Needle Inserter includes data derived from testing of multiple Inserters as well as performance testing to validate expected usable life duration.

NOTE 7: The predicate and subject devices operate in the same operational principle - the user must load the infusion set into the device, compress a spring and activate the device by pressing a trigger button. The force needed to load the AccuSert Needle Inserter and activate the release trigger were validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm.

NOTE 8: The predicate and subject devices operate in the same operational principle - the user must load the infusion set into the device, compress a spring and activate the device by pressing a trigger button. With the subject device (AccuSert Needle Inserter) the needles are inserted into the skin using slightly lower spring force than the predicate device. However, the slight difference in spring force does not have a safety or effectiveness impact. The AccuSert was designed with adequate force to insert the intended needle sets with the minimum force and impact to the patient skin as confirmed by conducted performance testing

NOTE 9: The AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation

NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS VII.

No clinical study is included in this submission.

The following performance data were provided in support of the substantial equivalence determinations:

Biocompatibility

The biocompatibility evaluation was conducted in accordance with the international standard EN ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within A Risk Management Process" as recognized by FDA. The battery of testing included the following:

Chemical Characterization (ISO 10993-18:2020 Biological evaluation of medical . devices - Part 18: Chemical characterization of medical device materials within a risk management process)
. Cytotoxicity (ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 testing for in vitro cytotoxicity)
Sensitization (ISO 10993-10:2021 Biological evaluation of medica devices Part 10 • tests for skin sensitization)
Skin Irritation (ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 tests for irritation)

The AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation.

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Design Verification

Various performance tests were conducted to provide objective evidence that the device retains its mechanical properties and functions with EMED subcutaneous administration needle sets which include:

Cocking Force .
. Trigger Force
Insertion Force •
Visual/Functional
. Life Cycle testing
. Chemical Resistance
Drop Test
Cleaning
Usability Evaluation

The aforementioned tests were completed compliant with the following standards:

ANSI/AAMI HE75:2009 (R2018) Human Factors Engineering Design of Medical ● Devices
IEC 62366-1:2015 Medical devices part 1, Application of usability engineering to medical devices
ISO 28620:2020 Medical devices Non-electrically driven portable infusion devices . (Standard used to perform the Drop Test)

Results from performance testing indicate that the product meets the established performance requirements.

VIII. FINAL CONCLUSION:

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K010377.

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).