The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.

Device Description

The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made of polypropylene.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for an Insulin Syringe (K233794). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria for an AI/ML algorithm.

Therefore, the information typically required to answer your request regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/ML-powered device is not present in this document.

This document describes a medical device, an insulin syringe, which is a physical product, not an AI/ML software. The performance data presented refers to standard physical and biological tests for such a device (e.g., sterilization, biocompatibility, needle strength, etc.), not the performance metrics of an AI algorithm.

Here's a breakdown of why this document doesn't fit your request and what is actually discussed:

Type of Device: The device is an "Insulin Syringe," a physical medical instrument for injecting insulin. It does not incorporate AI or machine learning.
Purpose of the Document: This is an FDA 510(k) clearance letter. Its primary purpose is to establish "substantial equivalence" of a new device to a legally marketed predicate device, allowing it to be marketed. This is a common regulatory pathway for non-novel medical devices.
"Acceptance Criteria" discussed: The "acceptance criteria" for a physical device like an insulin syringe are generally defined by recognized standards (e.g., ISO standards for sterile hypodermic needles, biocompatibility standards). The document states that performance testing was conducted "to ensure the substantial equivalence...and verify conformity to the applicable parts of ISO standards."
"Study" discussed: The "study" refers to a series of performance tests (e.g., ISO 7864:2016, ISO 9626:2016, ISO 8537:2016 for physical characteristics; Biocompatibility testing as per ISO 10993-1; Sterilization, shipping, and shelf-life validation). These are laboratory and bench tests, not clinical studies involving AI models.

In summary, as the provided text is for a physical medical device (Insulin Syringe) and not an AI/ML-powered device, it does not contain the information you requested regarding acceptance criteria and study data for AI/ML performance.

To answer your prompt for an AI/ML device, you would need a document detailing the validation of an AI algorithm, which would include information on metrics like sensitivity, specificity, AUC, human-in-the-loop studies (MRMC), ground truth establishment, training data, and more. This document does not pertain to such a device.

Summary

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March 6, 2024

SPM Medicare Pvt. Ltd. % Prithul Bom, Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114

Re: K233794

Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: March 6, 2024 Received: March 6, 2024

Dear Prithul Bom:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology 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) K233794

Device Name Insulin Syringe

Indications for Use (Describe)

The sterile Insulin Syringe is for single use, with the callbrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.

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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K233794 510k Summary

This 510k summary is being prepared in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

Device Submitter:	SPM Medicare Pvt. LtdB-40, Phase IIGautam Budh NagarNoida -201305,Uttar Pradesh, India
Contact Person:	Mr. Umang Mathur

Contact Person:	Mr. Umang Mathur
Position:	Managing DirectorTel : +91-971-100-8401Email:umang@spmmedicare.com

Designation Submission Correspondent Primary contact Person: Sanjay Kumar Position: Deputy Manager & (Management Representative) MR Tel:+91-8384011434 Email : sanjay.qa@spmmedicare.com Date of Preparation: February 7, 2024

II. DEVICE

ldentification of proposed device: Trade Name: Insulin syringe Common name: Insulin syringe

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Regulatory Information:

Regulation Name: Piston syringe Requlatory Class: Class II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

III Predicate Device

510(k) Number K223453 Product Name: Insulin Svringe Regulation Number: 21 CFR 880.5860 Product Code: FMF

Manufacturer Name:

Promisemed Hangzhou Meditech Co., Ltd. Zearou Yanq Requlatory affairs manager No. 1388, Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, Zhejiang 311121, China

IV: Device Description:

Device Range:

The proposed Insulin Syringe will be distinguished on the basis of their size and units. The 1 ml U-40 & U-100 syringes are being manufactured with different needle gauges, U-40 means 40 units of insulin in every Lm and U-100 means there are 100 units of insulin in every mL. The color code is used to identify the strength, where the red cap is used to identify U-40 units & the orange cap is used to identify U-100 units.

S. No.	Gauge	O.D of Needle	Length of Needle
1	28G	0.349 – 0.370 mm	6 mm, 8 mm, 12.7mm
2	29G	0.324 – 03.51 mm	6 mm, 8 mm, 12.7mm
3	30G	0.298 – 0.320 mm	6 mm, 8 mm, 12.7mm
4	31G	0.254 – 0.267 mm	6 mm, 8 mm, 12.7mm
5	32G	0.229 – 0.241mm	6 mm, 8 mm, 12.7mm

Nominal Capacity: 1 ml (U-40). 1 ml (U-100)

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V. INDICATIONS FOR USE

VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Item	Proposed Device (K233794)	Predicate DeviceK223453
Trade Name	Insulin Syringe	Insulin Syringe	Comments
Manufacturer	SPM Medicare Pvt. Ltd.	Promisemed Hangzhou MeditechCo., Ltd
Device Class	Class II	Class II	Same
Product Code	FMF	FMF	Same
Regulationnumber	880.5860	880.5860	Same
Regulation Name	Piston syringe	Piston syringe	Same
Intended Use/Indications forUse	The sterile insulin syringe forsingle use, with the calibrated unitof insulin for U-40 & U-100 is adevice intended for medicalpurposes for the manualaspiration of insulin, and for theinjection of insulin into parts of thebody below the surface skin. Thedevice is intended to be used foradults only.	Insulin Syringe is intendedfor subcutaneous injection ofU-40 and U-100 insulin inthe treatment of diabetes.	Same
Type of use	Prescription use and over the-counter use	Prescription use and over the-counter use	Same
Operating Principle	The insulin is injected tosubcutaneous tissue by pushingforce generated through pushingplunger rod of the insulin syringe.	The insulin is injected tosubcutaneous tissue bypushing force generatedthrough pushing plunger rodof the insulin syringe.	Same
Specific drug use	Insulin	Insulin	Same
Length	118mm	120mm	Different.Proposed device has118 mm length andpredicate device has120 mm length. Thisdoes not impact theintended use ofdevice.
Volume	1.0ml	0.3ml, 0.5ml, 1.0ml	DifferentOnly 1.0ml insulinsyringe is included forthe subject device
Needle length	6mm, 8mm, 12.7mm	6mm, 8mm, 12mm	Different.Compared to thepredicate device, theproposed device hasa difference in needlelength. The 12.7mmneedle length oftheinsulin syringesafety andperformance hasbeen confirmed bytesting. Thisdifference does notraise new question ofsafety andeffectiveness.
Needle gauge	32G, 31G, 30G, 29G, 28G	32G, 31G, 30G, 29G, 28G	Same
Needle tipconfiguration	3 bevels	3 bevels	Same
Nozzle type	Not applicable	Not applicable	Same
Numbering of scale	At every 10units for 1.0ml	At every five units for the 0.3mLand 0.5mL syringes, and at every10units for 1.0mL	SameThe proposeddevice has onlythe 1.0 mlcapacity & thepredicate deviceincludes a 0.5mLand 0.3ml model.The difference incapacity devicewill be selectedby the physicianper thepatient's condition.This difference doesnot affect intendeduse.
Gradationslegibility	Legible	Legible	Same
Needle coverdimensions	Length: 25mm, Diameter: 6mm	Length: 25mm, Diameter: 6mm	Same
Needle covercolour	Red (U-40) and orange (U-100)	Red (U-40) and orange (U-100)	Same
Lubricantcomposition	Aminofuntional siloxane	Aminofuntional siloxane	Same
Lubricantamount/cm2	The lubricant does not form poolsof fluid on the interior surface of thesyringe or outside surfaces of the	The lubricant does not formof fluid on the interiorsurface of the syringe or outside	Same
	needle tube.	surfaces of the needle tube.
Barrel transparency	Transparent	Transparent	Same
Needle coverstrength	<15N	<15N	Same
Hub/needle bondstrength	>22N	>22N	Same
Biocompatibility	No CytotoxicityNo irritation reactivityNo significant evidenceof skin sensitizationNo significant evidenceof systemic toxicityNo evidence of Hemolysis	No cytotoxicityNo irritation reactivity Nosignificant evidence ofskin sensitizationNo significant evidenceof systemic toxicityNo evidence of Hemolysis	Same
Configuration andMaterial	Needle: Stainless Steel (SS304)Barrel: PolypropylenePlunger: PolypropylenePiston: Polyisoprene rubberNeedle cap: PolypropyleneProtective end cap:Polypropylene	Needle: Stainless Steel(SS304)Barrel: PolypropylenePlunger: PolypropylenePiston: Polyisoprene rubberNeedle cap: PolyethyleneProtective end cap:Polyethylene	Different.The materials ofthe needle capand protectiveend cap aredifferentbetween theproposed deviceand predicatedevice. Thebiocompatibilitytest of theproposed devicewas conductedto demonstratethat the subjectdevice met thebiocompatibilityrequirements.This differencedoes not raiseany new safetyandeffectivenessquestions.
Label	Brand Name, Device name,indication, instruction for use,precaution, warning, shelf life,manufacturer	Device name, indication,instruction for use,precaution, warning,shelf life, manufacturer	Same
Sterilizationmethod and SAL	Sterilized by ethylene oxide gasSAL = 10-6	Sterilized by ethylene oxide gasSAL = 10-6	Same
Sterilizationmethod	EO Sterilization	EO Sterilization	Same
EO and ECHresidues testing	Conform ISO 10993-7	Conform ISO 10993-7	Same

Table 1 Comparison of Technology Characteristics

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Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

VII. Performance Data

Performance testing was conducted to ensure the substantial equivalence of the Insulin syringe throughout the shelf life and verify conformity to the applicable parts of ISO standards. No new question of safety and effectiveness were raised with the testing performed on the subject device when compared to the predicate device. The following performance tests were performed on the Insulin syringe using a fixed needle:

(i) ISO 7864:2016, Sterile hypodermic needles for single use -- Requirements and test methods (ii) ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods

(iii) ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin

Biocompatibility

In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (<24hours). The following testing was conducted:

Cytotoxicity ●
. Sensitization
Irritation or intracutaneous reactivity ●
Acute systemic toxicity
Pyrogenicity ●
Hemocompatibility ●
. Subacute systemic toxicity

Sterilization, Shipping and shelf life

(i) EO sterilization validation as per ISO11135-2014
(ii) Pyrogen testing as per USP <85> Bacterial Endotoxin Test
(iii) EO residual as per ISO 10997-7
(iv) Stimulated shipping as per ASTM D4169
(v) Sterile barrier Package testing performed on the proposed device (ISO 11138, IP)
(vi)Seal strength EN 868-5
Bubble test ASTM 2096 (vii)
Dye Penetration ASTM F1929-15 (viii)

Shelf life: Shelf life of 5 years validated using FDA recognized ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

VIII. CONCLUSION

The difference between the predicate and subject device do not raise any new different questions of safety or effectiveness.

The SPM manufactured Insulin syringe is substantially equivalent to Insulin Syringe in K223453.

IX. Summary of Similarities & Difference of subject device with the predicate device and Justification:

The subject device shares equivalent indications for use, device operation, and overall technical and

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functional capabilities to the predicate device. The difference in some materials of components, configuration, and sizes have been evaluated through non-clinical testing; the tests are in accordance with those established in the standards, ISO 7864-2016, ISO 9626:2016 & ISO 8537:2016. Therefore, the differences between the predicate device (K223453) and the subject device do not raise any new or different questions of safety or effectiveness. Performance testing data demonstrates that the proposed device is substantially equivalent to the predicate device with respect to the indications for use, target populations, and technological characteristics.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).