The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.

Device Description

The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, which are used to determine the exact catheter trim length. The PICC catheter is offered with or without plastic clamps on the proximal extension tubes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called a Peripherally Inserted Central Catheter (PICC). It specifically states that the device is being submitted as substantially equivalent to existing legally marketed devices.

Therefore, the document does not describe an acceptance criteria or a study that proves the device meets those criteria in the way one might expect for a novel AI/software device. Instead, the focus is on demonstrating equivalence to predicate devices.

Let's break down why and then address the specific points you requested based on the information provided:

Key Takeaway: This is a substantial equivalence submission, not a performance study for a novel algorithm.

Here's how to address your request based on the provided text, highlighting what's not applicable (N/A) due to the nature of a 510(k) substantial equivalence submission for a physical medical device:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified, as this is a substantial equivalence submission for a physical medical device. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a defined standard or clinical trial endpoint.	The device is substantially equivalent to the PICC catheters offered by Cook Inc. and Luther Medical.
Indicated for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. Distal catheter tip must provide maximum dilution for therapy and assurance of continued, uncompromised vascular access.	The PICC catheter system is designed for these indications, and the manufacturer believes it meets the minimum requirements for its intended use.
Made from polyurethane material with 5 cm incremental markings. Offered with or without plastic clamps.	The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, and is offered with or without plastic clamps on the proximal extension tubes.
Packaged in a heat-sealed Tyvek/mylar pouch. Sterilized using ethylene oxide gas. Bacterial endotoxin levels monitored.	The PICC catheter is packaged as described, sterilized using ethylene oxide gas, and bacterial endotoxin levels are monitored for sterility release purposes.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a physical medical device and relies on demonstrating substantial equivalence to existing predicate devices, not on a clinical performance study with a test set of data in the context of AI/software. There is no mention of a test set, data provenance, or study design for performance.
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. As there is no "test set" or performance data analysis in the AI/software context, there is no mention of experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set is described, so no adjudication method is mentioned.
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 is a physical medical device, not an AI/software device. No MRMC study or AI assistance is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As there is no clinical performance study involving AI/software analysis of data, the concept of "ground truth" as typically applied in AI studies is not relevant here. The "truth" in this context is that the device design, materials, manufacturing processes, and intended use are similar enough to predicate devices to ensure safety and effectiveness.
The sample size for the training set
- Not Applicable. This is a physical medical device. There is no training set for an algorithm.
How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (a catheter). The core of a 510(k) submission for such a device is to demonstrate substantial equivalence to devices already legally on the market. It does not involve performance studies, test sets, training sets, ground truth establishment, or AI/software specific criteria that you've listed.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K9805266'. The characters are written in a dark color, possibly black ink, against a light background. The style of writing is somewhat rough, giving it a hand-drawn appearance.

SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

A. GENERAL INFORMATION

	Owner Operator Submitting Boston Scientific Corporation
	this Premarket Notification: One Boston Scientific Place
	Natick, MA 01757
	(508) 650.9174
Contact Person:	Wanda M. Carpinella
	Regulatory Affairs Department
Device Generic Name:	Peripherally Inserted Central Catheter
Device Classification:	80 FOZ, Intravascular Catheter

B. INDICATIONS FOR USE

C. DESCRIPTIVE CHARACTERISTICS

D. SUBSTANTIAL EQUIVALENCE

The subject PICC catheter has been shown to be substantially equivalent to the PICC catheter offered by Cook Inc. and Luther Medical.

E. PACKAGING, STERILIZATION, AND PYROGENICITY

The PICC catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.

F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the PICC catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed PICC catheters.

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Public Health Service

SEP 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wanda M. Carpinella Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K980566 Vaxess Peripherally Inserted Central Trade Name: Catheter Regulatory Class: II Product Code: FOZ Dated: July 21, 1998 Received: July 23, 1998

Dear Ms. Carpinella:

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 leqally 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਸੋ 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 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

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Paqe 2 - Ms. Carpinella

through 542 of the Act for devices under the Electronic Product Radiation 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general -information on your responsibilities under the Act may be obtained from the Division 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,

S. Dutman for

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):

14980566 New Application

Device Name:

Peripherally Inserted Central Catheter

The PICC catheter system is designed for use when Indications for Use: indications for 800.
central venous catheterization or prolonged intravenous administration of fluids, Central verious catherenzation of profession in the mariety of insertion sites may medications, and/or harmond the patient involved and the catheter size selected. While be utilized, dopending apon the pay be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for used voin: Eoodtion of the alstarssary and assurance of a continued, uncompromised vascular access.

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)

Concurrence of CDRH, Office of Device Evaluaiton (ODE)

(Division Sign-Off) 75 . 1 Division of Deneral Infection Control, and General Hospital Devices 510(k) Number K 9 8 0

Prescription Use
(Per 21 CRF 801.109)

Over-The-Counter Use

(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).