The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device, the "Monoject® PreFill Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a study proving the device meets those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text.

The document primarily states that the device is "substantially equivalent in intended use, function and composition" to a predicate device and that "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Substantially equivalent in intended use to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245.	The proposed device is stated to be "substantially equivalent in intended use, function and composition" to the predicate device.
Function and Composition Equivalence: Substantially equivalent in function and composition to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245.	The proposed device is stated to have "the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing Heparin Lock Flush Solution, USP."
Biocompatibility: Meet the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.	Biocompatibility testing "has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."

2. Sample sized 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 specified in the document. The testing mentioned (biocompatibility) would involve a certain number of samples, but no specific count is provided.
Data Provenance: Not specified. Biocompatibility testing is typically performed in a laboratory setting, but the location or whether it's retrospective/prospective is not mentioned.

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 specified. This information is typically relevant for studies involving human interpretation (e.g., medical imaging AI). Biocompatibility testing is laboratory-based and doesn't involve "experts" establishing ground truth in the same way.

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

Not applicable/Not specified. This is relevant for studies involving human interpretation or complex data review, not for standard biocompatibility testing.

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. This document does not mention an MRMC study. The device is a syringe, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device. The testing described is for the physical and chemical properties of a medical device (syringe).

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

For biocompatibility, the "ground truth" would be the established safety standards and chemical/biological assay results as defined by ISO 10993 and FDA guidelines. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

Not applicable/Not specified. This document is not describing a machine learning model. If interpreted in the context of device development, "training set" might refer to early development samples, but no such details are provided.

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

Not applicable/Not specified. As above, this is not a machine learning context.

Summary

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EXHIBIT # 9

510(k) Summary

DEC 31 2001

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:

The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: November 26, 2001

1. Contact Person
  David A. Olson Director, Regulatory Affairs (508) 261-8530
1. Name of Medical Device
  Catheter, Intravascular, Therapeutic, Short-Term Classification Name: Common or Usual Name: Monoject® PreFill Heparin Lock Flush Syringe
1. Identification of Legally Marketed Device
  The proposed Kendall Monoject® PreFill Flush Syringe is substantially equivalent in intended use, function and composition to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245.
1. Device Description
  The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.
1. Device Intended Use
  The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
1. Product Comparison

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The proposed device has the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing Heparin Lock Flush Solution, USP.

7. Nonclinical Testing

Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2001

Mr. David A. Olson Director, Regulatory Affairs Tyco Healthcare Kendall Division 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K013556

Trade/Device Name: Monojet Pre-Fill Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Catheter, Intravascular, Therapeutic, Short-Term Regulatory Class: II Product Code: NGT Dated: October 24, 2001 Received: October 25, 2001

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.

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

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Page 2 - Mr. Olson

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 Of K Part 6077; lacemig (21 CFR Part 820); and if applicable, the electronic for an and quinny of eventions (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 promated predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 594-4618. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general 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,
Lillatoust

Timoth Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 013550

KO13556 510(k) Number (if known):

(ii known):
Monoject Pre Fill Heparin Lock Flush Syringe, 10 and 100 units/m Device Name:_

Indications For Use:

The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for The ricpanni Lock Pract: Syints, 2001 administration sets and indwelling intravenous access devices.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	(Per 21 CFR 801.109)
------------------	---------------------------------

Over-The-Counter Use	(Optional Format 1-2-96)
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Vick Hibbard for Pat Cricenti
'Division Sign-Off) Envision of Dental, Infection Control, and General Hospital Devices · Norober KO13556

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).