The Insignis® Subcutaneous Needle Sets are sterile, single use, packaged subcutaneous needle sets. Each Subcutaneous Needle Set has a luer lock at one end and a 90-degree 26G (0.46mm) needle mounted to a closing wing-stabilizer (or butterfly wings) at the distal end of one or more needles. The needles are available in four different lengths: 6mm, 9mm, 12mm, and 14mm. Each set has a slide clamp to stop the flow immediately as well as a butterfly wing that can be closed around the needle upon completion of the infusion. The Insignis® Subcutaneous Needle Sets is available as a single set, as well as a two, three and four needles sets.

The Insignis® Subcutaneous Needle Sets is designed to be used for less than 24 hours

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the "Insignis Subcutaneous Needle Sets." It is a regulatory document to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the performance of an AI-powered diagnostic device.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set details for an AI/diagnostic device is not present in this document.

This document describes a medical device (subcutaneous needle sets) and its equivalence to a predicate device based on physical characteristics, intended use, and conformance to various industry standards for manufacturing, materials, sterility, and biocompatibility.

To directly answer your request based only on the provided text, and noting the mismatch between the prompt's focus on AI/diagnostic acceptance criteria and the document's content:

Based on the provided FDA 510(k) document (K202279) for Insignis Subcutaneous Needle Sets:

The document describes the acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, not for an AI-powered diagnostic device. The performance claimed is related to the physical and functional attributes of the needle sets for medication delivery.

Here's an attempt to map the prompt's questions to the available information, while explicitly stating where the information is not applicable or present for an AI/diagnostic device:

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly met by conformance to recognized industry standards and comparison to a predicate device. The "performance" is demonstrating that the device functions as intended and is safe and effective when used as described.

Acceptance Criteria (Implicitly from Standards & Equivalence)	Reported Device Performance (Summary from Document)
Intended Use Equivalence:	Insignis Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours. This is "Same" as the predicate device (RMS Subcutaneous Needle Set, K102512).
Biocompatibility:	The device meets ISO 10993-1 and specific parts (5, 6, 10, 11) for biocompatibility (cytotoxicity, local effect after implantation, irritation, skin sensitization, systemic toxicity). Classified as Externally communicating device, Blood Path indirect, Limited Contact (<24 hours).
Sterility:	Achieves SAL 10-6. Sterilization method is E-beam, which is different from the predicate's Gamma but deemed to provide an identical level of sterility and undifferentiated outcome. Conforms to ISO 11137 series.
Physical/Functional Performance:	Conforms to various ISO standards for needle tubing (ISO 9626), Luer fittings (ISO 594-2), sharps injury protection (ISO 23908), hypodermic needles (ISO 7864), and infusion equipment (ISO 8536-9). Specific tests mentioned include: Simulated clinical Use, PKP testing with various fluids, Butterfly opening Force test, Butterfly Low memory Test, Fluid flow rates, Pull force testing.
Material Safety & Equivalence:	Materials (e.g., TPE tubing vs. PVC, PP luer vs. PVC) are stated to allow for biocompatibility and comparable performance. Stainless steel needles are identical to predicate.
Shelf Life:	Validated for 1 year shelf life. (Predicate is 3 years, but within their respective shelf lives, no performance difference is stated). Conforms to ISO 11607-1 for packaging integrity and sterile barrier.
Single Use:	Confirmed as single use, same as predicate.
Regulatory Compliance:	Device is found substantially equivalent to the predicate, implying compliance with general controls provisions of the FD&C Act.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI/diagnostic algorithm testing. Performance data is derived from product testing against various ISO standards. The sample size for each specific test (e.g., fluid flow rates, pull force testing, biocompatibility) is not detailed in this summary.
Data Provenance: The data originates from performance testing conducted by the manufacturer (Innovative Health Sciences LLC) and its consultants to demonstrate conformance with international standards and substantial equivalence. The country of origin for the data (where the tests were performed) is not specified, but the applicant is based in New York, USA. The studies would be considered prospective as they are conducted specifically for this regulatory submission.

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. This document is for a physical medical device (needle sets), not an AI-powered diagnostic device requiring expert interpretation for ground truth establishment. Performance is evaluated against objective engineering and biocompatibility standards.

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

Not Applicable. There is no expert adjudication process described or needed for this type of device's performance evaluation.

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:

Not Applicable. This is not an AI-powered diagnostic device, and no MRMC study was performed.

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

Not Applicable. This is not an AI-powered diagnostic device.

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

Ground Truth: The "ground truth" for this device's performance is established by conformance to established international standards (ISO series) for medical devices. This includes verifiable physical, chemical, and biological properties, as well as functional performance metrics (e.g., flow rates, material strength, sterility levels) measured objectively by laboratory testing. There is no qualitative "ground truth" derived from human interpretation or patient outcomes data described in this 510(k) summary beyond the standards themselves.

8. The sample size for the training set:

Not Applicable. This document describes a physical medical device, not an AI model requiring a training set.

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

Not Applicable. This document describes a physical medical device, not an AI model requiring a training set.

Summary

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August 13, 2021

Innovative Health Sciences, LLC Shepard Bentley Official Correspondent 1108 Kings Highway, Suite 4 Chester, New York 10918

Re: K202279

Trade/Device Name: Insignis Subcutaneous Needle Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: June 30, 2021 Received: July 8, 2021

Dear Shepard Bentley:

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,

Payal Patel 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202279

Device Name Insignis® Subcutaneous Needle Sets

Indications for Use (Describe)

Insignis® Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.

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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510k Summary K202279

Submitter

Innovative Health Sciences LLC

1108 Kings Highway Suite 4

Chester, NY 10918

Phone: 845-610-5665

Contact: Andy Sealfon

Email: andy@innohealthsci.com

Date Prepared: August 2, 2021

Official Correspondent

Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677 Phone: 949-374-9187 Email: sbentley@bentleybiomed.com Contact Person: Shepard G. Bentley, RAC

Name of Device: Insignis® Subcutaneous Needle Sets Common or Usual Name: Subcutaneous Needle Set Classification Name: Intravascular Administration Set Classification Regulation: 21 CFR 880.5440 Regulatory Class: II Product Code: FPA Classification Panel: General Hospital

Predicate Device: RMS Subcutaneous Needle Set (K102512)

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Device Description

The Insignis® Subcutaneous Needle Sets is designed to be used for less than 24 hours

Intended Use

The Insignis® Subcutaneous Needle Sets are used to administer fluids from a container to a patient's subcutaneous tissues.

Characteristics	Subject DeviceInsignis®SubcutaneousNeedle SetK202279	Predicate Device:RMS SubcutaneousNeedle Set(K102512)	Comment
Indications forUse	Insignis® SubcutaneousNeedle Sets are intendedfor the delivery ofmedication to thesubcutaneous tissue foruse not to exceed 24hours.	RMS SubcutaneousNeedle Sets are intendedfor the delivery ofmedication to thesubcutaneous tissue foruse not to exceed 24hours.	same
RX or OTC	Rx	Rx	same

Indications for Use

There is no difference in intended use or Indications for Use between the subject device and the predicate device.

Summary of Technological Characteristics

Subject Device	Predicate Device	Comment
Insignis®Subcutaneous NeedleSet	Device: RMSSubcutaneousNeedle Set

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	K202279	(K102512)
IntendedUse/Indications forUse	Insignis® SubcutaneousNeedle Sets are intendedfor the delivery ofmedication to thesubcutaneous tissue foruse not to exceed 24hours.	RMS SubcutaneousNeedle Sets are intendedfor the delivery ofmedication to thesubcutaneous tissue foruse not to exceed 24hours.	Same
Duration of use	24 hours	24 hours	Same
Intendedpopulation	Adults and pediatrics	Adults and pediatrics	Same
Environment of use	Hospital, clinic, long-term care, home use	Hospital, clinic, long-term care, home use	Same
Sterility	SAL 10-6	SAL 10-6	Same
SterilizationMethod	E-beam	Gamma	DifferentComment #1
Single Use?	Yes	Yes	Same
Tubing Length(in)	24	20	DifferentComment #2
Tubing Material	TPE	PVC	DifferentComment #3
Needle Material	Stainless Steel	Stainless Steel	Same
Needle Gauge	26	26	Same
Needle Length(mm)	6, 9, 12, 14	6, 9, 12	DifferentComment #4
Number ofsets	1-4 needle sets	1-6 needle sets	DifferentComment #5
Female Luer	Polypropylene (PP)	PVC	DifferentComment #6
Butterfly	Polypropylene (PP)	Polypropylene	Same
Shelf Life	1 year	3 years	DifferentComment #7
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Same

The following differences are discussed:

Comment #1 Sterilization method: Both devices apply radiation sterilization and utilize the VD Max method of ensuring terminal sterility; however, the E-beam approach provides a focused method that allows an identical level of sterility as the alternative Gamma approach which relies upon a proximity method to a radioactive source. The outcomes from each method allow undifferentiated sterility, although the E-beam results in less yellowing of the material, generally.

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Comment #2-Tubing Length: The subject device is 24 inches as compared to the predicate device which is 20 inches, and the difference in the length of the subject device tubing does not represent a change in performance and is based upon patient feedback since the debut of the predicate device.

Comment #3-Tubing Material: The subject device uses TPE while the predicate device uses PVC, as either material allows for biocompatibility and the same performance of the tubing. The TPE is less stiff and easier to use than PVC.

Comment #4-Needle Length: The subject device offers an extra needle set length of 14 mm, which itself represents the only difference from the predicate device, as the other needle lengths at 6 mm, 9 mm and 12 mm are identical. The subject device's extra set with a longer length nevertheless represents a substantially equivalent overall set of needle length options, and represents comparable performance. in view of the fact that the predicates of the predicate all had 14 mm length needle sets, as well. Presently, the predicate device offers the 14 mm needle length.

Comment #5-Number of Sets: The subiect device has four sets versus the six sets of the predicate device; however, the overall performance remains comparable with regard to infusion volumes, as the volume of drug per site has increased since the predicate device was cleared.

Comment #6-Female Luer: The subject device luer material is polypropylene (PP) and the predicate device luer material is PVC; however, the materials provide comparable performance of the luer fittings.

Comment #7-Shelf Life: The subject device has been tested to one year of shelf life, whereas the predicate device has been tested to three years of shelf life. Within the respective shelf lives of the devices, no difference between the performance of the subject device and the predicate device pertains.

The information provided in the premarket notification demonstrates that the subject device, Insignis® Subcutaneous Needle Sets, are substantially equivalent to the legally marketed predicate device.

The subject device and the predicate device are intended to be used for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir. Insignis® subcutaneous Needle Sets are identical in performance, physical properties, using similar materials and having the same indications for use as the predicate device. Each device includes needle sets with butterfly wings, tubing, clamps and luer connectors. The differences described above do not raise new or different questions of safety and effectiveness.

Performance Data

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The following standards were applied for performance testing

ISO 9626:1991/AMD1:2001 Stainless steel needle tubing for the manufacture of medical devices - requirements and test methods

ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process

ISO 10993-2:2006 Biological Evaluation of Medical Devices – Part 2: Animal Welfare requirements

EN ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Test for in vitro cytotoxicity

ISO 10993-6:2016 Biological Evaluation of Medical Devices – Part 6: Tests for local effect after implantation

ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization

EN ISO 10993-11:2018 Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity

EN ISO 10993-12:2012 Biological Evaluation of Medical Devices – Part 12: Sample Preparation and reference material

EN ISO 11137-1: 2015 Sterilization of Health Care Products – Radiation – Part 1:

Requirements for development, validation, and routine control of a sterilization process for medical devices (include. Amendment 1, 2013)

EN ISO 11137-2:2015 Sterilization of Health Care Products - Radiation - Part 2: Establishing the sterilization dose

ISO 11137-3:2017 Sterilization of Health Care Products - Radiation - Part 3: Guidance on dosimetric aspects of Development, validation, and routine control

EN ISO 11737-1:2006 Sterilization of Health Care Products - Microbial methods, Part 1: Estimation of the population of microorganisms (incl. Technical Corrigendum)

EN ISO 11737-2:2009 Sterilization of Health Care Products - Microbial methods, Part 2: Tests of sterility performed In the definition, validation and maintenance of sterilization process

AAMI TIR 29:2012 Guide for Process Characterization Control in Radiation Sterilization 0f Medical Devices

ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 594-2: 1998Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

ISO 28620:2020 Medical Devices - non-electrically driven portable infusion devices

ISO 23908:2013 Sharps injury protection - Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and

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needles use for blood sampling

ISO 7864:2016 Sterile hypodermic needles for single use – Requirements and test methods

ISO 8536-9:2015 Infusion equipment for medical use - {art 9: Fluid lines for single use with pressure infusion equipment

ISO 14971:2019 Medical Devices-App

IEC 62366-1:2015 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

The needle sets described in this summary were tested and demonstrated to be in conformance with the following standards:

. ISO 9626:2001 Stainless steel needle tubing for the manufacture of medical devices-requirements and test methods
ISO 594-2:
Simulated clinical Use
ISO 23908:2011 ●
PKP testing with various fluids ●
Butterfly opening Force test
Butterfly Low memory Test
Fluid flow rates
Pull force testing

Biocompatibility Testing

In accordance with ISO 10993-1, the subcutaneous needle sets are classified as: Externally communicating device, Blood Path indirect, Limited Contact (<24 hours). The following testing was conducted:

ISO 10993-5:2009 ●
ISO 10993-6:2016 ●
ISO 10993-10:2010 ●
ISO 10993-11:2018 ●

Sterility/Shipping/Shelf life

. Standard -package integrity testing/transportation
- o ISO 11607-1:2019

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Sterile barrier package testing . o ISO 11607-1:2019
. Shelf life of 1 year validation
- 0 Real time aging
- o ISO 11607-1:2019

Conclusions

The differences between the predicate and the subject devices do not raise any new or different questions of safety or effective. The Insignis® Subcutaneous Needle Sets are substantially equivalent to the RMS Subcutaneous Needle Set (K102512) with respect to the indications for use, target population, and technological characteristic.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.