The proposed device is intended for the subcutaneous injection of U-100 Insulin.
Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.

Device Description

These devices are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with a 30g x 5/16 inch needle.

AI/ML Overview

The provided text describes the 510(k) summary for the Monoject® Insulin Syringe, which focuses on a design change involving a new, smaller gauge needle. The submission aims to demonstrate substantial equivalence to existing legally marketed devices.

However, the document does not contain the detailed information required to fill out the table and answer the study-related questions thoroughly. Specifically, it lacks:

Explicit acceptance criteria with specific numerical targets. The document mentions conformance to ISO 8537:1991(E) but doesn't detail which specific parameters were tested against which criteria.
Reported device performance in a quantifiable manner against predefined criteria.
Descriptions of a study methodology that would include sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Details on the training set for an AI/algorithm, as this is a physical medical device (syringe with a needle), not an AI/software device.
The type and establishment of ground truth in the context of an AI/algorithm, as it's not applicable here.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted or inferred based on the document's nature (510(k) for a physical device) and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific numerical criteria for physical and functional properties, e.g., plunger force, needle sharpness, dosage accuracy, sterility, material biocompatibility. (Not explicitly stated in the provided text, but implied by conformance to ISO 8537 and general medical device regulations.)	Specific test results demonstrating compliance with the criteria, e.g., "Plunger force within X-Y range," "Needle penetration force < Z," "Dose accuracy within +/- N%," "Sterility Assurance Level achieved," "Biocompatibility demonstrated per ISO 10993." (Not explicitly stated in the provided text; the document only states it conforms to ISO 8537 except for the new needle gauge and some marking requirements.)
Conformance to ISO 8537:1991(E) "Sterile single-use syringes, with or without needle, for insulin" (excluding the 31-gauge needle presence and certain marking requirements).	Implied to be met, as the submission seeks substantial equivalence. No specific performance data provided, only a statement of conformance.
The new 31-gauge needle is identical in materials, design, and intended use to 31-gauge x ½" insulin needles currently marketed by Becton-Dickinson.	Implied to be met by declaring substantial equivalence. No specific performance data provided to compare.

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

Sample Size: Not specified in the provided text. For a physical device like a syringe, testing would involve batches of manufactured units.
Data Provenance: Not specified, but generally, for such devices, testing is conducted within the manufacturer's facilities or certified testing laboratories in the country of manufacture (e.g., USA, as the company is based in Mansfield, MA). The testing would be prospective, occurring during design verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This question is typically relevant for AI/software devices where "ground truth" relates to clinical annotations or diagnoses. For a physical device, testing involves engineering and laboratory assessments against functional and safety standards (e.g., material scientists, quality engineers, metrology specialists, sterility experts). No clinical expert "ground truth" establishment as understood in AI studies is mentioned or implied for this type of device submission.

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

Not Applicable. This is a concept used in expert-based annotation or labeling for AI model training/testing. For a physical device, compliance is determined by objective measurement against engineering specifications and regulatory standards, typically through pass/fail criteria.

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. An MRMC study is not relevant here as the device is a physical insulin syringe, not an AI/software product or an imaging device requiring human interpretation.

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

No. This question applies to AI/software. This is a physical medical device.

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

For a physical device like an insulin syringe, "ground truth" refers to established engineering specifications, medical device standards (like ISO 8537), and regulatory requirements for safety and performance (e.g., sterility, biocompatibility, dosage accuracy, material properties, mechanical strength, needle sharpness). It's based on objective measurements and laboratory tests rather than clinical "expert consensus" on an image or diagnosis.

8. The sample size for the training set

Not applicable. This question pertains to AI/machine learning models. A physical device does not have a "training set" in this context. Design and manufacturing processes are refined through engineering, quality control, and testing, but not "trained" with data in the same way an algorithm is.

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

Not applicable. As above, there is no "training set" for a physical device.

Summary

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EXHIBIT # 9

510(k) Summary

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: October 17, 2003

Contact Person 1.
David A. Olson Vice President, Regulatory Affairs (508) 261-8530
1. Name of Medical Device
  Monoject Insulin Syringe Trade Name: Piston Syringe Classification Name: Insulin Syringe Common or Usual Name:

3. Identification of Legally Marketed Device

The proposed Kendall Monoject® Insulin Syringe are substantially equivalent in intended use, design and function to Becton Dickinson's Ultra - Fine™ II Insulin Syringe, 510(k) No. K024112 and the Kendall Monoject Insulin Syringe, 510(k) No. K991758.

Device Description 4.

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5. Device Intended Use

The proposed device is intended for the subcutaneous injection of U-100 Insulin.

6. Summary of Technological Characteristics

The only design change being incorporated into current Monoject Insulin Syringes compared to currently marketed Monoject Insulin Syringes is the addition of a new needle size – 31 Gage x 5/16" Length. This needle is of smaller diameter than the current Monoject 30 Gage x 5/16" Length insulin needle. All other aspects are identical to current Monoject Insulin Syringes. Monoject Insulin Syringes conform to International Standard ISO 8537:1991(E) "Sterile single-use syringes, with or without needle, for insulin", except in regard to the presence of the 31 gage (0.26 mm OD.) needle which is not contained in the standard and in regard to certain marking requirements.

The new Monoject 31 Gage x 5/16" insulin needle is identical in materials, design and intended use to 31 Gage x ½ " insulin needles currently marketed by Becton-Dickinson.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

NOV 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tyco HealthCare Mr. David A. Olson Vice President, Regulatory Affairs Kendall 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K033373

Trade/Device Name: Monoject® Insulin Syringe Regulation Number: 880.5570, 880.5860 Regulation Name: Hypodermic Single Lumen Needle Piston Syringe Regulatory Class: II Product Code: FMI Dated: October 17, 2003 Received: October 22, 2003

Dear Mr. Olson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Olson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ¿c 3 33 7 3

Device Name: Monoject® Insulin Syringe

Indications for Use: Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.

Please Do Not Write Below This Line - Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Pataria Cuccente

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K033375

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).