In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Peripherally Inserted Central Catheter.

AI/ML Overview

This 510(k) submission (K964929) describes a Peripherally Inserted Central Catheter (PICC) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about the performance of an AI/ML powered device, nor does it detail a study that establishes acceptance criteria for such a device. Instead, it describes general safety and effectiveness testing for a medical device.

Therefore, many of the requested sections regarding acceptance criteria for an AI device, specific study designs, data provenance, expert ground truth, and comparative effectiveness studies cannot be answered from the provided text.

Here's an attempt to answer the applicable sections based only on the provided text, while making it clear where the information is not present or not relevant to AI/ML device performance.

Acceptance Criteria and Study for K964929 (Peripherally Inserted Central Catheter)

This 510(k) submission is for a conventional medical device (Peripherally Inserted Central Catheter) and not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, ground truth, and specific study designs for AI systems is not present in the provided text. The "acceptance criteria" and "device performance" described relate to the physical and functional characteristics of the catheter, not an algorithm's output.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for an AI/ML component. Instead, it states that "All finished products are tested and must meet all required release specifications before distribution." and lists general categories of testing:

Acceptance Criteria Category	Reported Device Performance
Material Suitability	Materials tested according to ISO Standard 10993; suitable for intended use.
Physical Testing	Meets defined Quality Control Test Procedure documents and product design specifications.
Visual Examination	Meets required standards during in-process and finished product inspection.
Sterility & Biocompatibility	(Implied by ISO 10993 and general medical device standards, but not explicitly detailed as a performance metric in the text beyond material suitability)

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

Not applicable to an AI/ML powered device. For this physical device, testing is conducted on "all finished products" before distribution, indicating a 100% inspection or testing rate for release. The data provenance is intrinsic to the manufacturing process of the medical device itself.

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

Not applicable to an AI/ML powered device. The "ground truth" for this device relates to its physical properties and functionality, verified through standardized tests and design specifications rather than expert interpretation of data.

4. Adjudication method for the test set

Not applicable to an AI/ML powered device. The "adjudication method" for this device involves established testing procedures and parameters defined by Quality Control Test Procedure documents, with approval, release, and revision in accordance with GMP's.

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 comparative effectiveness study was not done, as this is not an AI/ML powered device.

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

Not applicable, as this is not an AI/ML powered device.

7. The type of ground truth used

For this medical device, the "ground truth" is based on:

Compliance with ISO Standard 10993 for material biocompatibility.
Adherence to product design specifications.
Fulfillment of Quality Control Test Procedure documents.
Results from physical testing and visual examinations.

8. The sample size for the training set

Not applicable, as this is not an AI/ML powered device. There is no concept of a "training set" for a physical medical device.

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

Not applicable, as this is not an AI/ML powered device.

Summary

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K964929

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA 90

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400

December 4, 1996

JUN - 2 1997

Mark S. Alsberge, Regulatory Affairs Manager Contact:

Product Name: Peripherally Inserted Central Catheter

Trade Name: Cavafix

Classification name:

Cardiovasular Class II, 80FOZ, 21 CFR 880.5200

SUBSTANTIAL EQUIVALENCE1 TO:

510(k) number	Name	Applicant
K861479	Cavafix	B. Braun Medical Inc.
UNKNOWN	SoloPICC	SoloPak

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Peripherally Inserted Central Catheter.

1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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Material:

The Peripherally Inserted Central Catheter is composed of materials that have been tested in accordance with and the ISO Standard 10993 for this category. The materials have been determined to be suitable for the intended use of this product.

Substantial equivalence:

The Peripherally Inserted Central Catheter is similar in materials, form, and intended use to the Cavafix cleared by B. Braun Medical Inc. and the SoloPICC manufactured for SoloPak. There are no new issues of safety or effectiveness raised by Peripherally Inserted Central Catheter.

Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark S. Alsberge Manager, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018

JUN - 2 1997

K964929 Re: Trade Name: ACCUGUIDE® Multilumen Catheter Regulatory Class: Unclassified Product Code: LJS Dated: March 25, 1997 Received: March 28, 1997

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.q., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual reqistration, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP

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inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

In addition, we have determined that your device kit contains the following which are subject to regulation as drugs:

米 alcohol swabsticks,
- Povidone-Iodine swabsticks,
- 10 ml. ampul, 0.9% NaCl,
- skin protectant prep pad,
Teqaderm™ dressing, and メ
★ 5 ml. ampul of Lidocaine HCl, 1%.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063

This letter will allow you to begin marketing your device as described in your 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket

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notification" (21 CFR 807.97). Other general information on nocircation (2) of oth ooder the Act, may be obtained from the your responsibilities andor ors Assistance at its toll free Division Or Smarr HanaraCtarers (301) 443-6597, or at its internet address "dsmo@fdadr.cdrh.fda.goy".

Sincerely yours,
Alatorre

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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510(k) Number (if known):

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Device Name: Peripherally Inserted Central Catheter Indications For Use:

K964929

The indication for use is when the patient's condition requires the peripheral intusio

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Cardiovascu and Neurological Devi 510(k) Numbe

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”