The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Device Description

Designed for peripheral vein catherization .
Comprised of a polyurethane material o
The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
Clamps are provided on the extension tube to prevent air/fluid communication. 0
Female luer connectors provide the connection for intravenous administration. 0

AI/ML Overview

The provided text describes a medical device, the 2.6F Vascu-PICC®, and its 510(k) submission for substantial equivalence to a predicate device. The document primarily focuses on the regulatory approval process and includes information about the device's design, intended use, and the performance testing conducted to support its safety and effectiveness.

However, the text does not contain information related to an AI/ML device or a study that would involve acceptance criteria for an AI model's performance in terms of metrics like sensitivity, specificity, or accuracy, which is what your request is about.

In this context, the entire section related to "Acceptance Criteria and Study for AI/ML Device" cannot be fulfilled as the input document is for a physical medical catheter, not an AI/ML diagnostic or prognostic tool.

Therefore, many of the requested categories in your prompt are not applicable to this document. I will fill in the applicable information about the device performance and acceptance criteria from this specific document.

Acceptance Criteria and Study for the 2.6F Vascu-PICC® (Physical Medical Device)

This document details the 510(k) submission for a physical medical device, the 2.6F Vascu-PICC®, not an AI/ML device. Therefore, the acceptance criteria and supporting studies are focused on the physical characteristics, biocompatibility, and performance of the catheter itself, rather than AI model metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standard Met)	Reported Device Performance
Biocompatibility	ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices.	Met (Subject product testing yielded acceptable safety and performance outcomes).
General Catheter Requirements	ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Requirements.	Met (Subject product testing yielded acceptable safety and performance outcomes).
Central Venous Catheter Requirements	ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous Catheters.	Met (Subject product testing yielded acceptable safety and performance outcomes).
Luer Lock Fittings	ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and a Certain Other Medical Equipment - Part 2: Lock Fittings.	Met (Subject product testing yielded acceptable safety and performance outcomes).
Risk Management	Internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices.	Analysis did not identify any new types of safety or efficacy questions for the proposed device.
Substantial Equivalence	Demonstrates equivalence in design, materials, sterilization, and indications for use to the predicate device (1.9F Vascu-PICC®, K091466).	Based on indications for use and safety/performance testing, the device meets the requirements and is substantially equivalent.

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

Sample Size: Not explicitly stated for each test. The document refers to "subject product testing" which implies tests were performed on a sample of the 2.6F Vascu-PICC® devices, but the exact number of units tested for each standard is not provided.
Data Provenance: The tests were conducted by Medcomp, the manufacturer ("internal protocol based on ISO 14971: 2000"). The document does not specify the country of origin of the data beyond the manufacturer's location (Harleysville, PA, USA). The studies appear to be prospective testing of the manufactured device.

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

Not Applicable. This is a physical device submission. Ground truth in the context of expert consensus on diagnostic images or clinical outcomes is not relevant here. The "ground truth" for these tests would be the established international standards (ISO standards) themselves, which define the acceptable parameters for device performance.

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

Not Applicable. This concept pertains to resolving discrepancies among expert readers in AI/ML validation studies. For direct performance testing against international standards, the results are typically objectively measured and compared to the standard's defined acceptance limits.

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 type of study involves AI assistance for human interpretation, which is not relevant for this physical medical device.

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

Not Applicable. There is no algorithm being evaluated in this submission.

7. The type of ground truth used:

The ground truth for this device's performance is objective measurements against established international standards such as ISO 10993, ISO 10555-1, ISO 10555-3, and ISO 594-2. For risk management, the "ground truth" is adherence to ISO 14971.

8. The sample size for the training set:

Not Applicable. No AI model is being trained.

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

Not Applicable. No AI model is being trained.

Summary

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DEC 2 1 2010

510(k) Summary 2.6F Vascu-PICC®

Summary of Safety and Effectiveness Prepared October 1, 2010

K102966

General Information

Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Phone: (215) 256-4201Fax: (215) 256-9191
Contact:	Jean CallowRegulatory Specialist
Device Trade Name:	2.6F Vascu-PICC®
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	LJS - Catheter, Intravascular, Therapeutic, Long-TermGreater than 30 Days
CFR Reference:	21 CFG 880.5970, Class II
Classification Panel:	General Hospital

Predicate Devices:

Device Trade Name:	1.9F Vascu-PICC®
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	LJS-Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days
CFR Reference:	21 CFR 880.5970, Class II
Classification Panel:	General Hospital
Premarket Notification:	K091466

Indications for Use: The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripherally insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Device Description:

Designed for peripheral vein catherization .
Comprised of a polyurethane material o
The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
Clamps are provided on the extension tube to prevent air/fluid communication. 0
Female luer connectors provide the connection for intravenous administration. 0

Safety and Performance Tests

Medcomp 2.6F Vascu-PICC® 510(k) Summary Page 1 of 2

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Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met.

Performance testing of the 2.6F Vascu-PICC® was conducted in accordance with the following international standards:

ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General . . Requirements
ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and a Certain Other Medical Equipment - Part 2: Lock Fittings

Subject product testing has vielded acceptable safety and performance outcomes.

Risk Management of the subject device was conducted in accordance with an internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. The analysis did not identify any new types or safety or efficacy questions for the proposed device.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 2.6F Vascu-PICC® is substantially equivalent to the cited predicate device.

Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the 2.6F Vascu-PICC® meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate device.

5-2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national affiliation. The logo is simple, using a black and white color scheme.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville Pennsylvania 19438

DEC 2 1 2010

Re: K102966 Trade/Device Name: 2.6F Vascu-PICC® Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 1, 2010 Received: December 2, 2010

Dear Ms. Callow:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. ·

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Page -- Ms Callow

Enclosure .

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fas

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, İnfection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

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Indications for Use

DEC 2 1 2010

510(k) Number (if known): Kl 0296 6

Device Name: 2.6F Vascu-PICC®

Indications for Use:

Prescription Use X_
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rild C. Chay 12/20
(Division Sign-Off)

Page 1 of 1

rDivision Olgh Only rection Control, Dental Devices

10(k) Number: K102966

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.”