(37 days)
Not Found
Not Found
No
The device description is a simple saline solution, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as Saline Topical Solution used for moistening and lubricating wound dressings, which is a supportive rather than a direct therapeutic function. Its intended use is more aligned with wound care and hygiene than direct treatment of a disease or condition.
No
Explanation: The device is a saline topical solution used for moistening and lubricating wound dressings, which is a therapeutic or supportive function, not a diagnostic one. It does not identify or detect diseases or conditions.
No
The device description clearly states it is a physical vial containing a saline solution, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for moistening and lubricating wound dressings prior to removal from the wound area. This is a topical application for wound care, not for testing or examining specimens in vitro (outside the body).
- Device Description: The device is a saline solution for topical use. IVDs typically involve reagents, instruments, or systems used to test biological specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
30-ml. polyethylene vial containing Saline Topical Solution, 0.9% w/v Sodium Chloride Solution. Single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Dec-22-99 01:03P
ﺭﯾﺎﮞ ﻣﯿﮟ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍ
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 LL
Mr. Howard Rose
President and CEO |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 325 North Water Street
Batavia, IL 60510 |
| Telephone | 630-406-8680 |
| Contact Person. | Philip Totton
Authorized Regulatory Agent
210 Silver Creek Road
Greer, South Carolina 29650
Telephone: 864-292-0756
Fax: 864-244-9049 |
| Date Prepared: | November 19, 1999 |
| Trade Name. | Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v
Sodium Chloride |
| Common Name: | Normal Saline Topical Solution, 0.9% w/v Sodium Chloride |
| Classification Name | Solution, Wound Dressing |
| Predicate Device. | Steripak Limited
20 ml. Normal Saline Topical Solution
0.9% 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 dressings
for traumatic wounds, cuts, bruises and minor burns prior to
removal from the wound area. |
| Substantial Equivalence. | The product is similar in function and intended use to Steripak 20
ml. Normal Saline Topical Solution manufactured by Steripak
Limited and includes among it's labeled uses for moistening and
lubricating absorbent wound dressing. |
1
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
3
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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 Solution
0.9% w/v Sodium Chloride |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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 |
(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)
() (ત્ર
Over - the - Counter Use
Nemili cayane fir 520
(Division Sign-l Division of Gen 510(k) Number
P.03