The subiect device is a 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride. It is used for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Normal Saline Topical Solution 0.9% w/v is a unit-dose low density polyethylene vial containing a. clear, colourless, aqueous solution. Normal Saline Topical Solution contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.

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

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

Not applicable/Not provided. The document does not define explicit acceptance criteria or report performance metrics in the way one would for a clinical or analytical study. The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. No test set or associated sample size is mentioned, as this is not a study reporting new performance data. The submission relies on a comparison to a predicate device.

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/Not provided. No ground truth establishment is described, as there is no test set or study being conducted in this context.

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

Not applicable/Not provided. No test set or adjudication method is described.

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/Not provided. No MRMC study or AI assistance is mentioned. This device is a topical solution, not an AI-assisted diagnostic tool.

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

Not applicable/Not provided. This is not an algorithm-based device.

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

Not applicable/Not provided. No ground truth is established or used in the context of a performance study for this submission. The "ground truth" for the 510(k) equivalence claim is the performance and safety profile of the predicate device.

8. The sample size for the training set

Not applicable/Not provided. No machine learning model or training set is mentioned.

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

Not applicable/Not provided. No machine learning model or training set is mentioned.

Summary of what is available from the document:

The document is a 510(k) summary for a medical device. The "study" (or rather, the basis for clearance) is a comparison of the subject device to a predicate device to demonstrate substantial equivalence.

Device Name: 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride
Intended Use: For moistening and lubricating absorbent wound dressings prior to removal from the wound area.
Predicate Device: Brennen Medical, Incorporated's Sterile Saline Solution (510(k) K935060, cleared on January 10, 1994).
Basis for Equivalence: The subject device is a topical sterile saline solution classified as a "liquid bandage" with the same intended use as the predicate device.
Claimed Equivalence: "Although there are technological differences between the subject device and the predicate device, these technological differences do not raise new questions of safety and effectiveness."

The provided text simply states that a comparison was made to support substantial equivalence, but it does not detail the specific data or tests performed for that comparison, nor does it provide performance acceptance criteria beyond the general requirement of not raising new safety or effectiveness concerns.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Steripak" in large, bold, black letters, with a wavy line underneath. To the right of the word is the number "K9722195" in a similar bold, black font. Below the number, the date "MAR - 5 1998" is printed in a smaller, lighter font.

510(k) Summary

"This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92".

ું જ "The assigned 510 (k) number is ______________________________________________________________________________________________________________________________________________ K972185

1. Submitter Information

Steripak Limited Goddard Road, Astmoor Runcorn , Cheshire WA7 1QF England

Contact Person:

Steve Forrester-Coles Site Operations Director

Phone: 44-1-928-579110 FAX: 44-1-928-579540

2. Name of Device

Trade/Proprietary Name:	20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride
Common/Usual Name:	Normal Saline Topical Solution 0.9%w/v Sodium Chloride
Classified Name:	Liquid Bandage

3. Predicate Device

The predicate device identified for the substantial equivalence claim is Brennen Medical, Incorporated's Sterile Saline Solution. This product is distributed by Brennen Medical, Inc. under their 510 (k) K935060, Brennen Medical Sterile Saline Solution, cleared on January 10, 1994. This product is classified as a Liquid Bandage. Brennen Medical's Sterile Saline Solution is an 8 fluid ounce pressurised container of sterile, isotonic buffered solution containing sodium chloride, boric acid, sodium borate and purified water. The Brennen Medical product is for moistening and lubricating absorbent wound dressings prior to removal from the wound area.

Steripak Limited, Goddard Road, Astmoor, Runcorn, Cheshire WA7 1QF (Registered Office) Telephone: (01928) 579110 Fax: (01928) 579540 Registered No. 1273708

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Description of the Subject Device 4.

Intended Use of the Subject Device 5.

The Normal Saline Topical Solution 0.9% w/v is for moistening and lubricating absorbent wound dressings prior to removal from the wound area. To use, the plastic unit-dose vial is first separated from the strip of vials then opened by twisting off the top of the vial. The solution in the plastic unit-dose vial is dispensed using one of two methods. To achieve a directional stream of solution, squeeze firmly. To obtain drop by drop dispensing, invert the vial and squeeze gently. Normal Saline Topical Solution 0.9% w/v is a single use product. Any solution remaining in the plastic unit-dose vial should be discarded.

Technological Characteristics of the Subject Device Compared to the 6. Predicate Device

The predicate device identified for the substantial equivalence claim is Brennen Medical Incorportated's Sterile Saline Solution. The subject device, and the predicate device. Brennen Medical's Sterile Saline Solution are both topical sterile saline solutions classified as a "liquid bandage" intended for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Comparison for the Normal Saline Topical Solution 0.9% w/y product and the Brennen Medical product supports that they are substantially equivalent. Details of the substantial equivalence claim are provided in Attachments 3 through 8. Although there are technological differences between the subject device and the predicate device, these technological differences do not raise new questions of safety and effectiveness.

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Signature of Applicant

Steripak Limited,

John William Holloway BSc. CChem MRSC MBIRA Head of Product Development and Regulatory Affairs

Signature

29th October 1997

Date

Steripak Limited, Goddard Road, Astmoor, Runcorn, Cheshire WA7-1QF (Registered Office) Telephone: (01928) 579110 Fax: (01928) 579540 Registered No. 1273708

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected and appear to be emerging from a single point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

John William Holloway BSc. Cchem MRSC MBIRA John William - Development and Regulatory Affairs Steripak Limited Goddard Road, Astmoor Runcorn, Cheshire WA7 1QF England

K972185 Re: R972189
20mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride Regulatory Class: Unclassified Product Code: FRO Dated: February 4, 1998 Received: February 6, 1998

Dear Mr. Holloway:

This letter corrects our substantially equivalent letter of March 5, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 9 ro(t); premation is substantially equivalent to
device referenced above and have determined the semmerce prior to May 28 device referenced above and have decemined the esstate commerce proor to May 28, 1976, legally marketed predicate device manies or to devices that have been the enactment date of the Medical Device Punctions of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal (DMA) . You may, reclassified in accordance with the provisions of the volual (PMA). You may, therefore,
(Act) that do not require approval of a premarket approval (PMA). The general (Act) that do not require approval of a provisions of the Act. The general
market the device, subject to the general controls provisions were registration, listing of market the device, subject to the general one provinces for annual registration, listing of controls provisions of the Act filelums requirements .
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:

This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 – Mr. John William Holloway BSc. Cchem MRSC MBIRA

This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

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.

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 continue 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.

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Page 3 – Mr. John William Holloway BSc. Cchem MRSC MBIRA

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for

Mark N. Melkerson

DEP

1/24/07

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications For Use Statement

K972185 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.

(Please Do Not Write Below This Line - Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use

Over-The-Counter Use

(Per 21 CFR § 801.109)

(Division Sian-Off) Division of General Restorative Devices 972185 510(k) Number

Regulation Number and Section

N/A