SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

• K Number: K993969
• Device Name: SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
• Manufacturer: WINCHESTER LABORATORIES LLC.
• Date Cleared: 1999-12-30 ( 37 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: K040683 , K201138

Intended Use

For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, bruises and minor burns prior to removal from the wound area

Device Description

30-ml. polyethylene vial containing Saline Topical Solution, 0.9% w/v Sodium Chloride Solution. Single-use.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The documents are related to a 510(k) premarket notification for a medical device called "Saljet Single Dose Sterile Saline Topical Solution" and primarily consist of an S10K Summary and an FDA letter confirming substantial equivalence.

These documents describe:

• The submitter and contact information.
• The trade name, common name, and classification name of the device.
• The predicate device.
• A description of the device.
• Indications for use.
• A statement of substantial equivalence to a predicate device.
• FDA's letter of substantial equivalence.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

Summary

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Dec-22-99 01:03P

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P.08

Image /page/0/Picture/3 description: The image shows a sequence of numbers and a symbol. The sequence starts with a symbol that looks like a multiplication sign or the letter 'K'. Following this symbol are the numbers 993969. The numbers and symbol are written in a bold, handwritten style, giving them a distinct and somewhat artistic appearance.

DEC 3 0 1999

Revしし、12・リゾ

Section 15
S10K Summary
Page 1 of 1

Submitter:	Winchester Laboratories LLMr. Howard RosePresident and CEO
Address	325 North Water StreetBatavia, IL 60510
Telephone	630-406-8680
Contact Person.	Philip TottonAuthorized Regulatory Agent210 Silver Creek RoadGreer, South Carolina 29650Telephone: [phone]Fax: [phone]
Date Prepared:	November 19, 1999
Trade Name.	Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/vSodium Chloride
Common Name:	Normal Saline Topical Solution, 0.9% w/v Sodium Chloride
Classification Name	Solution, Wound Dressing
Predicate Device.	Steripak Limited20 ml. Normal Saline Topical Solution0.9% w/v Sodium Chloride
Description	30-ml. polyethylene vial containing Saline Topical Solution, 0.9%w/v Sodium Chloride Solution. Single-use.
Indications for Use	For use in moistening and lubricating absorbent wound dressingsfor traumatic wounds, cuts, bruises and minor burns prior toremoval from the wound area.
Substantial Equivalence.	The product is similar in function and intended use to Steripak 20ml. Normal Saline Topical Solution manufactured by SteripakLimited and includes among it's labeled uses for moistening andlubricating absorbent wound dressing.

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Image /page/1/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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and professional, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

Mr. Howard Rose President and Chief Executive Officer Winchester Laboratories, LLC 325 North Water Street Batavia, Illinois 60510

K993969 Re:

Trade Name: Saljet Single Dose Sterile Saline Topical Solution Regulatory Class: Unclassified Product Code: FRO Dated: November 19, 1999 Received: November 23, 1999

Dear Mr. Rose:

This letter corrects our substantially equivalent letter of December 30, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the we nave reviewed your Doctor of t(-) == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == = = = = = = = = = = = = = = = = = = = = = = = = device referenced above and readers) to legally marketed predicate devices marketed Indications for ass stated in the May 28, 1976, the enactment date of the Medical Device In interstate commerce proof to may 20, 27 rolassified in accordance with the provisions of Amendinents of to dev, and Cosmetic Act (Act) that do not require approval of a the Federal Pood, Drug, and Cobinette, revy (1978). Market the device, subject to the general promarket approvisions of the Act. The general controls provisions of the Act include controls provisions of the rion ation 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 If your device is classified (occ aso ro) into cols. Existing major regulations affecting your (FMA), it may be subject to adements of Federal Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Features concerning your device in the Federal Register.

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Page 2 - Mr. Howard Rose

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 moun that I Dr Frass mad regulations and regulations administered by other requirements of the Novels comply with all the Act's requirements, including, but not I card 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 This lector will and w you to really 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

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

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Image /page/3/Picture/1 description: The image shows a sequence of numbers and letters written in a bold, handwritten style. The sequence appears to be "K993969". The characters are thick and slightly irregular, giving them a distinct, hand-drawn appearance. The overall impression is that of a quickly written or stylized numerical code.

Rev 01, 12/99

Section 3 Intended Use of Device Page I of I

Device Name:	Saljet Single Dose Sterile Saline Topical Solution0.9% w/v Sodium Chloride
Indications for Use	For use in moistening and lubricating absorbent wound dressings fortraumatic wounds, cuts, bruises and minor burns prior to removal from thewound area

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Usc (Per 21 (FR 801 1/00)

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Over - the - Counter Use

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(Division Sign-l Division of Gen 510(k) Number

P.03

Regulation Number and Section

N/A