(69 days)
Not Found
No
The provided text describes a wound gel and its intended uses. There is no mention of any computational or analytical capabilities, let alone AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is a wound gel indicated for the management of various wounds, including minor cuts, burns, abrasions, and ulcers, which are conditions that require therapeutic intervention for healing.
No
The device is a wound gel applied for the management of wounds, not to diagnose a condition. Its function is to support healing by providing a moist environment.
No
The device description clearly states it is 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/Indications for Use: The intended use describes the management of various types of wounds (burns, abrasions, cuts, ulcers, surgical wounds). This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a gel applied to the wound surface to create a moist environment for healing. This is a topical treatment, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is clearly intended for wound care and healing, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Over The Counter:
L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts.
Prescription (Rx):
Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
Product codes
FRO
Device Description
L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
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: Lay User
Prescription (Rx): 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)
Not Found
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
510(K) SUMMARY
Name of 510(k) sponsor:
Address:
GlycoBioSciences, Inc.
7 Timber Court Georgetown, Ontario L7G 4S4 Canada
Contact information:
Kevin Drizen President GlycoBioSciences, Inc. 7 Timber Court Georgetown, Ontario L7G 4S4 Canada Phone: 905-854-0631 Fax: 905-702-1709
Dressing, Wound And Burn, Hydrogel W/Drug
Date summary prepared:
L.A.M. IPM Wound Gel Proprietary name of device:
September 21, 2012
And/Or Biologic
Generic/classification name:
Product code (classification): Product Code FRO: Unclassified
Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413); February 10, 1999 L.A.M IPM Wound Gel (K020325); April 15, 2002
Device Description:
L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
DEC 1 1 2012
Page 1 of 2
1
Intended Use:
Over The Counter:
L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts.
Prescription (Rx):
Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
Comparison with Predicate Device:
There have not been any changes to L.A.M IPM Wound Gel (K020325) since FDA determined that it was substantially equivalent to ConvaTec's HA Absorbent Wound Dressing (K984388) and Fidia Pharmaceutical Corporation's Bionect® Hydrogel (K984413) on April 15, 2002.
| Trade Name | L.A.M. IPMT™ Wound
Gel
(K020325) | Bionect® Hydrogel
(Jaloplast™)
(K984413) | L.A.M. IPMTM Wound Gel
(Not Yet Assigned -
modified indication) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Hydrogel Wound and
Burn Dressing | Hydrogel Wound and Burn
Dressing | Hydrogel Wound and Burn
Dressing |
| Intended Use | Provides a moist wound
environment that is
supportive to wound
healing | Provides a moist wound
environment that is
supportive to wound
healing | Provides a moist wound
environment that is
supportive to wound healing |
| Indication for Use | Over-the-counter:
• Minor abrasions
• Minor cuts | Over-the-counter:
• Minor burns
• Superficial cuts
• Lacerations and
abrasions
• Minor skin irritations | Over-the-counter:
• Minor burns
• Minor abrasions
• Minor cuts
Rx:
Under the care of a healthcare
professional: |
| | Under the care of a
healthcare professional:
• Wounds such as leg
ulcers, pressure
ulcers, and diabetic
ulcers
• Mechanically or
surgically debrided
wounds | Under the care of a
healthcare professional:
• Wounds such as partial
to full thickness dermal
ulcers (pressure ulcers,
venous stasis ulcers,
arterial ulcers, diabetic
ulcers)
• Surgical wounds (post-
operative incisions and
donor sites)
• Second degree burns | • Wounds such as leg
ulcers, pressure ulcers,
and diabetic ulcers
• Mechanically or
surgically debrided
wounds
• Surgical wounds (post-
operative incisions and
donor sites)
• Second degree burns |
. K123113 pg 2/2
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a title or heading. The font is sans-serif and the color is black.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Glycobiosciences. Incorporated % Focal Point Research, Incorporated Mr. Kevin Drizen President 7 Timber Court Gerogetown, Ontario L7G 4S4 Canada
Re: K123113 Trade/Device Name: L.A.M. IPM Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated (Date on orig SE ltr): September 25, 2012 Received (Date on orig SE Itr): October 03, 2012
Dear Mr. Drizen:
This letter corrects our substantially equivalent letter dated December 11, 2012.
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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Kevin Drizen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours. For
Peter D. Romm -S
Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
4
K123113
Indications for Use
510(k) Number (ff known): K123113
Device Name: L.A.M. IPM Wound Gel
Indications For Use:
"OTC:
L.A.M. IPM Wound Gel is indicated for the manugement of minor burns (16 degree burns), minor abrasions and minor cuts.
Rx:
Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and 2nd degree burns"
Prescription Use _ ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung. Dang
(Division Sign-Off) Division of Surgical Devices 510 (k) Number _______________________________________________________________________________________________________________________________________________________________
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