Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.

Device Description

Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.

AI/ML Overview

The provided text describes a 510(k) summary for "Soothies Gel Pads," a nipple shield. The focus of the document is on establishing substantial equivalence to predicate devices, primarily through material composition and intended use, rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or interventional device.

Therefore, many of the requested elements for describing a study and acceptance criteria are not applicable (N/A) based on the provided text, as this is a regulatory submission for a Class I device and not a performance study report.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a dedicated study.

Acceptance Criteria	Reported Device Performance
N/A	N/A

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as the document does not describe a performance study with a test set in the traditional sense. The safety evaluation mentioned a "residue of acrylamide gel" and its potential ingestion, but this is a risk assessment, not a performance study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. No test set or ground truth establishment by experts for performance measurement is described in the document.

4. Adjudication Method for the Test Set

This information is not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The document does not describe an MRMC comparative effectiveness study, nor does it quantify human reader improvement with or without AI assistance, as AI is not a component of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical nipple shield, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. Type of Ground Truth Used

This information is not applicable. No performance study with a defined ground truth is described. The "safety" section mentions an "evaluation" based on acrylamide monomer, but this is a risk assessment, not a ground truth for a performance metric.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as the device is a physical product and not an AI/algorithm-based system requiring training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

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Section 5

2006 FEB 9

510(k) Summary

Soothies

Contact Person: Ms. Leslie Sebastian Title: President and CEO Address: 9853 Pacific Heights Boulevard; Suite L; San Diego, CA 92121 Phone: (858) 228-1660 Fax: (858) 228-1650 Email: Leslies@soothies.com Establishment Registration Number: Pending Regulation Number: Classification: 880.5630 Device Class: 1 Common Name, Device: Nipple Shield Regulation Medical Specialty: General Hospital Review Panel: General Hospital

Intended Use

Description of Device

Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.

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KC52858

Predicate Devices

Soothies and ElastoGel Occlusive Gel are substantially equivalent because they are made of the same material.

Soothies are also substantially equivalent to the Ameda Comfort Gel Hydrogel Pads and the Breast Therapy Soothing Gel Patches because they have the:

Same intended use 제
. Same indicated target population
. Same environment of use, and
Same or similar design "

Safety

The differences between Soothies and its predicate devices do not adversely affect the safety or effectiveness of the product. Although Soothies, the Ameda Comfort Gel Hydrogel Pads, and the Breast Therapy Soothing® Gel Patches contain some different materials, as described below, numerous studies have demonstrated the safety of Soothies.

Puronyx has had the safety of Soothies studied for any potential health risk to a nursing infant and mother attributable to acrylamide monomer in the acrylamide polymer gel component of Soothies. The evaluation assumes that a residue of acrylamide gel is present on the mother's breast following her use of the pad and is subsequently ingested by the infant. The evaluation demonstrates that the heath risks to a nursing infant and an adult woman using the pads are de minimis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 9

Ms. Leslies Sebastian President and CEO Puronxy, Incorporated 9853 Pacific Heights Boulevard, Suite L San Diego, California 92121

Re: K052858

Trade/Device Name: Smoothies® Gel Pads Regulation Number: 880.5630 Regulation Name: Nipple Shield Regulatory Class: I Product Code: NXH Dated: January 25, 2006 Received: January 26, 2006

Dear Ms. Sebastian:

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 promarket 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.

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Page 2 - Ms. Sebastian

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,

Sylvia y. Michael Oms

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): K052828

Device Name: Soothics® Gcl Pads

Indications for Use:

Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples.

Prescription Use Frescription Ose
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Cim
Page 1 of 1

Ancy, Ceneral Hospital,

K452658

Regulation Number and Section

§ 880.5630 Nipple shield.

(a)
Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.