The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.

Device Description

Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".

AI/ML Overview

This 510(k) summary describes a medical device, the Keystone Medical Peripherally Inserted Central Catheter (PICC), and asserts its substantial equivalence to a predicate device (Medical Components, Inc. K#953811). The submission is for a device that is identical to the predicate device, with the only difference being the branding (Keystone Medical name and logo).

Therefore, the submission does not include any new studies or acceptance criteria for device performance as it relies entirely on the substantial equivalence to the predicate device, which had previous non-clinical (bench) testing. There are no clinical tests performed for this 510(k) submission.

Here's a breakdown of why the requested information cannot be provided from the given document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that non-clinical (bench) testing was completed for the predicate device (K#953811) and was included with this 510(k). However, the specific acceptance criteria and detailed performance results are not attached or described in this summary.
2. Sample size used for the test set and the data provenance: Not applicable. No new studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new studies were performed.
4. Adjudication method for the test set: Not applicable. No new studies were performed.
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 device is a physical medical device (catheter), not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device.
7. The type of ground truth used: Not applicable for new studies. For the predicate device, it would have been physical/mechanical testing data (e.g., tensile strength, flow rates).
8. The sample size for the training set: Not applicable. No new studies were performed, and it's a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relies on the previous approval of an identical predicate device. The provided text explicitly states that "Clinical testing was not completed" and "Non clinical (bench) testing was completed to support K#953811, and was included with this 510(k) submission." Therefore, the specific details of performance and acceptance criteria for this particular submission are not described beyond the claim of substantial equivalence to the predicate.

Summary

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Keystone Medical PICC Catheters 510(k) Summary

JUN 2 7 2001

Attachment 1

510(K) SUMMARY

This summary of 510(k) -safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5|0(k) number is:

Submitter's Identification: 1.

Tony Madison, President Keystone Medical 1338 Michael Way Lansdale, PA. 19446

Date Summary Prepared: May 29, 2001

2. Name of the Device:

Keystone Medical Peripherally Inserted Central Catheter (PICC)

3. Predicate Device Information:

These devices are substantially equivalent to devices currently marketed by Medical Components, Inc. Lansdale, PA under K#953811. Medical Components will continue to manufacture these devices.

4. Device Description:

Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".

5. Intended Use:

6. Comparison to Predicate Devices:

The Keystone Medical Lumen Catheter is identical to the predicate.

The Keystone device will differ only in that the Keystone Medical name and logo will appear on the unit labels, box labels, and instructions for use. Keystone will also develop it's own sell sheets for these devices in the future.

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ll 8660

Attachment 1

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Non clinical (bench) testing was completed to support K#953811, and was included with this 510(k) submission

Discussion of Clinical Tests Performed: 8.

Clinical testing was not completed.

9. Conclusion

The Keystone Medical PICC catheters are safe and effective for their intended use.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

JUN 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Keystone Medical C/O Mr. Alan P. Schwartz Executive Vice President MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re : K011860 Trade/Device Name: Keystone Medical PICC Catheter Regulation Number: 880.5200 Requlatory Class: II Product Code: FOZ Dated: June 12, 2001 Received: June 14, 2001

Dear Mr. Schwartz:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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Page 2 - Mr. Schwartz

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does entb response or obligation you might have under sections 531 not arress and of the Act for devices under the Electronic chrough 312 or on control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate with your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaraciasmostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). J Other general information on your responsibilities under the Act may be Information on your color of Small Manufacturers 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,

Timothy A. 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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Keystone Medical PICC Catheter Indications for Use

Attachment 3

of イ Page

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Keystone Medical PICC Catheters

Indications for Use:

(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

Petuna Cacciste

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4011840 1510(k) Number -

(Optional Format 1-2-96)

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).