(74 days)
Not Found
No
The device description and intended use describe a wound gel, and there is no mention of AI, ML, or any computational analysis of data.
Yes
The device is intended for the management and treatment of various wounds, including ulcers, which is a therapeutic purpose.
No
The device is described as a wound gel for treating minor cuts, abrasions, and various types of ulcers, which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly identifies the device as a "clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the application of the gel to wounds (minor abrasions, cuts, ulcers) for healing and management. This is a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the composition and physical properties of the gel, consistent with a topical wound care product.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Clinical Experience: The provided performance information focuses on the safety of the gel in treating wounds, not on the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional. L.A.M. IPM Wound Gel is suitable for oxuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the managemont of mechanically or surgically debrided wounds.
Product codes
MGQ
Device Description
I...A.M. IPM™ Wound Gel is a clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. Over-the-counter use of I.A.M. IPM™ Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional, J.A.M. IPM™ Wound Gol is suitable for exuding wounds such as log ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
I .. A.M. IPM™ Wound Gol has been subject to in viro biocompatibility testing (cytotoxicity, dermal irritation, dermal sensitization, hemolyisis, and aculc toxicity tests). These tests were negative and support the safe use of L.A.M. IPM™ Wound Gel as a hydrogel temporary dressing in contact with breached or compromised skin.
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
Over-the-counter use; Under the supervision of a healthcare professional
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)
Clinical experience in 27 patients with various types of non-healing ulcers indicates that L.A.M. JI'M Wound Gel is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 1 5 2002
510(k) Premarket Notification I.A.M. IPM™ Wound Gel
C. 510(k) Summary
Submitter:
Dow Pharmaceutical Sciences 1330A Redwood Way Petaluma, CA 94954 Phone: (707) 793-2600 Fax: (707) 793-0145
On Behalf of: L.A.M. Pharmaceutical Corp. 755 Center Street, Unit 5 Lewiston, NY 14092 Phone: (716) 754-2002 Fax: (716) 754-2043
January 30, 2002
L.A.M. IPM™ Wound Gel
Contact:
Alan Drizen C.E.O., L.A.M. Pharmaccutical, Corp.
l)atc:
Device Name:
Classification Name:
Predicate Device:
Hydrogel Wound and Burn Dressing Bionect® Ilydrogel (K984413) (Fidia Pharmaceutical Corp.)
IIA Absorbent Wound Dressing (K984388) (Convallec)
Description:
I...A.M. IPM™ Wound Gel is a clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. Over-the-counter use of I.A.M. IPM™ Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional, J.A.M. IPM™ Wound Gol is suitable for exuding wounds such as log ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
I .. A.M. IPM™ Wound Gol has been subject to in viro biocompatibility testing (cytotoxicity, dermal irritation, dermal sensitization, hemolyisis, and aculc toxicity tests). These tests were negative and support the safe use of L.A.M. IPM™ Wound Gel as a hydrogel temporary dressing in contact with breached or compromised skin.
Clinical experience in 27 patients with various types of non-healing ulcers indicates that L.A.M. JI'M Wound Gel is safe for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
APR 1 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
L.A.M. Pharmaceutical Corporation c/o Mr. Clawson Bowman, JD, RAC Dow Pharmaceutical Sciences 1330A Redwood Way Petaluma, CA 94954
Re: K020325
Trade/Device Name: L.A.M. IPM Wound Gel Regulatory Class: Unclassified Product Code: MGQ Dated: January 30, 2002 Received: January 31, 2002
Dear Mr. Bowman:
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 premarket 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.
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.
2
Page 2 - Mr. Clawson Bowman, JD, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Pago of
510(k) Nunber (if known): K020325
Device Name:__________________________________________________________________________________________________________________________________________________________________ Wound Gel
Indications For Usc:
Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional. L.A.M. IPM Wound Gel is suitable for oxuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the managemont of mechanically or surgically debrided wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTROL SECTION)
(IFLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off Division of Gene i, Restorative and Neurologica. evices
510(k) Number K020325
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)