(268 days)
Not Found
No
The device is a simple saline solution for wound dressing lubrication and does not involve any computational or analytical processes that would utilize AI/ML. The description focuses on the chemical composition and intended use as a topical solution.
No
The device is used for moistening and lubricating wound dressings, which is a supportive function and not directly therapeutic in treating the wound itself. Its active ingredient, normal saline, is not considered a therapeutic drug in this context.
No
The device is a normal saline solution used for moistening and lubricating wound dressings. Its intended use does not involve diagnosing medical conditions or diseases.
No
The device description clearly states it is a topical solution in a vial, which is a physical product, not software.
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 absorbent wound dressing prior to removal from the wound area." This is a topical application for wound care, not for testing samples taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description confirms it's a "Normal Saline Topical Solution" used for wound dressing removal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is applied in vivo (to the body) for a therapeutic/supportive purpose related to wound care.
N/A
Intended Use / Indications for Use
The Normal Saline Topical Solution 0.9% w/v is for moistening and lubricating absorbent wound dressings prior to removal from the wound area.
20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
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.
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
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
1
Image /page/1/Picture/0 description: The image shows the word "Steripak" in a bold, sans-serif font. The word is black and is positioned at the top of the image. Below the word is a curved line that resembles a wave.
Description of the Subject Device 4.
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.
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.
2
Image /page/2/Picture/0 description: The image shows the word "Steripak" in a bold, black font. Underneath the word is a black, wavy line. The line appears to be a single, continuous stroke that curves up and down.
- 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
3
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.
4
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.
5
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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Image /page/6/Picture/0 description: The image shows the word "Steripak" in a bold, sans-serif font. To the right of the word is the number "K972185" in a handwritten style. Underneath the word "Steripak" is a wavy line.
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