The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.

The device is intended to cushion the localized area surrounding the port.

Device Description

The thickness of the foam ring, along with the hole in the center of the ring, aids in preventing things, such as seat belts, bra straps, and clothing, from rubbing against the embedded port. The product consists of one element; an off-white colored flat ring made out of non-latex hypoallergenic foam, with a die cut hole in the middle, with non-latex adhesive backing.

AI/ML Overview

The provided text describes the "Foam Ring Port Protector" by Inspired Ideas, Inc. and its 510(k) summary. However, it does not contain detailed acceptance criteria or a study proving the device meets those criteria in the format requested.

The document mentions that "Compression testing was conducted on the foam and peel strength testing was conducted with the adhesive," but it doesn't provide the specific acceptance criteria for these tests (e.g., minimum compression strength, minimum peel strength) or the results obtained.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document (Only mentions "Compression testing was conducted on the foam and peel strength testing was conducted with the adhesive," but no results or targets are provided.)

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: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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. The "ground truth" concept is more relevant to diagnostic devices that interpret data (like images). This device is a physical accessory. The performance testing described (compression, peel strength) would likely use objective measurements rather than expert human interpretation.

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

Not applicable. Adjudication methods are typically for subjective expert evaluations of diagnostic results, which is not the case here.

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 is a physical accessory, not an AI or diagnostic device that involves human readers.

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

No. This is a physical accessory, not an algorithm.

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

Not applicable in the conventional sense. The "ground truth" would be the objectively measured physical properties of the materials (e.g., actual compression resistance, actual peel strength, material composition). The document only states that "Compression testing" and "peel strength testing" were conducted, implying objective measurement, but doesn't detail the target values or methods beyond that.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set.

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

Not applicable.

Summary

{0}------------------------------------------------

K062261 f. iot/

510(k) Summary Adhesive Foam Ring Inspired Ideas, Inc.

510(k) Summary

APR - 9 2007

Submitter Information

Allison Scott 11460 N. Meridian St., Suite 150 Carmel, IN 46032 (317) 569-9500 x106 Phone: (317) 569-9520 Facsimile:

Contact Person: Allison Scott

April 5, 2007 Date:

Foam Ring Port Protector Trade Name:

Infusion Port Accessory Common Name:

овк Classification Number:

Device Description

Intended Use(s)

The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.

The device is intended to cushion the localized area surrounding the port.

Performance Testing

Compression testing was conducted on the foam and peel strength testing was conducted with the adhesive.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inspired Ideas, Incorporated C/O Ms. Allison Scott Official Correspondent Anson Group, LLC 11460 North Meridian Street, Suite 150 Carmel, Indiana 46032

APR - 9 2007

Re: K062261

Trade/Device Name: Foam Ring Port Protector Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: OBK Dated: March 27, 2007 Received: March 28, 2007

Dear Ms. Scott:

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.

{2}------------------------------------------------

Page 2 - Ms. Scott

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); 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.

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 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oves

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Foam Ring Port Protector

Indications for Use:

The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.

The device is intended to cushion the localized area surrounding the port.

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

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ars

Sign-Off)
General Hospital,

X(k) No. K062261

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.