(75 days)
The LTM Wound Dressing is intended for the management of wounds including:
- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers: -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); +
- Draining wounds -
- And other bleeding surface wounds.
The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.
The device is intended for single patient, one time use only.
The LTM Wound Dressing device is identical in materials and construction to the Company's rno DTM Wound Droomigical Mesh (K070560). Like the LTM Surgical Mesh, LTM Wound Dressing consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thickness, and packaged in a double pouch configuration.
The provided 510(k) summary for the LTM Wound Dressing does not describe a study that uses acceptance criteria in the way typically seen for AI/ML device performance. Instead, it relies on a Substantial Equivalence argument based on a predicate device.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and the Reported Device Performance
Not applicable in the traditional sense for this submission. The "acceptance criteria" for this 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance is deemed acceptable if it is comparable to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (LTM Wound Dressing) |
|---|---|
| Safe and effective for intended uses. | "as safe and as effective as the legally marketed predicate devices" |
| Same or similar indications for use. | Has "the same intended uses and the same or similar indications" as predicate devices. |
| Same or similar technological characteristics. | "identical in materials and construction" to LTM Surgical Mesh (K070560); "same or similar technological characteristics" as predicate devices. |
| Same or similar principles of operation. | Has "the same or similar... principles of operation as its predicate devices." |
| Biocompatible. | Based on LTM Surgical Mesh testing, device is "biocompatible." |
| Manufacturing process capable of inactivating viral components. | Based on LTM Surgical Mesh testing, manufacturing process is "capable of inactivating any viral components." |
| Functions as intended. | Based on LTM Surgical Mesh testing, "functioned as intended and the performance observed was as expected." |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. There was no specific "test set" for the LTM Wound Dressing itself. The submission leverages data from the LTM Surgical Mesh (K070560), which previously underwent testing. The document does not specify the sample sizes or data provenance for that historical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a test set is described. The assessment is based on the previously established safety and effectiveness of the predicate device (LTM Surgical Mesh) and the new device being technologically identical.
4. Adjudication Method for the Test Set
Not applicable. No test set or associated adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device submission for a physical wound dressing, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated for the LTM Wound Dressing as it relies on substantial equivalence. For the predicate LTM Surgical Mesh, the "performance data" included "biocompatibility testing, animal implantation testing, and biomechanical testing." These types of tests likely relied on:
- Biocompatibility: Standardized assay results.
- Animal Implantation: Histopathological analysis, clinical observation, and potentially outcomes data from animal models.
- Biomechanical Testing: Quantitative measurements of physical properties.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set or associated ground truth establishment.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" that proves the LTM Wound Dressing meets the acceptance criteria is a demonstration of technological identity and substantial equivalence to a previously cleared device, the LTM Surgical Mesh (K070560).
The key arguments are:
- Technological Identity: The LTM Wound Dressing is "identical in materials and construction" to the LTM Surgical Mesh.
- Leveraging Prior Data: The LTM Surgical Mesh "has undergone extensive biocompatibility testing, animal implantation testing, and biomechanical testing."
- Equivalence of Data: Because the devices are technologically identical, the "testing conducted on the LTM Surgical Mesh is equally applicable to the LTM Wound Dressing."
- Conclusion: This similarity allows the conclusion that the LTM Wound Dressing is "as safe and as effective" as its predicate devices.
Therefore, the "proof" is based on the direct transferability of established safety and performance data from a predicate device due to their identical nature. There was no new clinical or performance study specifically for the LTM Wound Dressing described in this 510(k) submission.
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082103 1/3
OCT 0 8 2008
510(K) SUMMARY III.
LifeCell Corporation's LTM Wound Dressing
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Phone: (908) 947-1131 Facsimile: (908) 947-1095
Contact Person: Manal Morcos
Date Prepared: July 24, 2008
Names of Device and Name/Address of Sponsor:
LTM Wound Dressing LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Common or Usual Name
Collagen Wound Dressing
Classification Name
Dressing, Wound, Collagen
Classification:
Unclassified
Product Code:
KGN
Predicate Devices:
Pegasus Biologics, Inc. - Unite Biomatrix (K071425) LifeCell Corporation - LTM Surgical Mesh (K070560)
{1}------------------------------------------------
Intended Use / Indications for Use
The LTM Wound Dressing is intended for the management of wounds including:
- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers: -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, ﺘﻌ wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); +
- Draining wounds -
- And other bleeding surface wounds.
The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.
The device is intended for single patient, one time use only.
Technological Characteristics
The LTM Wound Dressing device is identical in materials and construction to the Company's rno DTM Wound Droomigical Mesh (K070560). Like the LTM Surgical Mesh, LTM Wound Dressing consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thickness, and packaged in a double pouch configuration.
Performance Data
LifeCell's LTM Wound Dressing is technologically identical to the cleared LTM Surgical Mesh (K070560). The LTM Surgical Mesh has undergone extensive biocompatibility testing, animal (1007030). The tivation testing, and biomechanical testing. The data indicates that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come with the starting material. In all instances, the LTM Surgical Mesh functioned as intended and the performance observed was as expected. As LTM Wound Dressing is the exact same device technologically as the LTM Surgical Mesh, the Company submits that testing conducted on the LTM Surgical Mesh is equally applicable to the LTM Wound Dressing.
Substantial Equivalence
The LifeCell LTM Wound Dressing is as safe and as effective as the legally marketed predicate devices, Pegasus Biologics, Inc.'s Unite Biomatrix (K071425), and LifeCell Corporation's LTM Surgical Mesh (K070560). The LifeCell LTM Wound Dressing has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as its predicate devices. Performance data demonstrates that LifeCell's LTM Wound
{2}------------------------------------------------
Dressing is as safe and effective as the predicate device. Thus, LifeCell's LTM Wound Dressing is substantially equivalent to the predicate devices.
:
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
LifeCell Corporation % Manal Morcos Manager, Regulatory Affairs One Millenium Way Branchburg, New Jersey 08876
Re: K082103
Trade/Device Name: LTM Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: July 24, 2008 Received: July 25, 2008
Dear Manal Morcos:
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.
{4}------------------------------------------------
Page 2 - Manal Morcos
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.
Sincerely vours.
Mark M. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT II.
11082103 510(k) Number (if known):_
Device Name: LTM Wound Dressing
Indications for Use:
The LTM Wound Dressing is intended for the management of wounds including:
- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers; -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); ・
- Draining wounds -
- And other bleeding surface wounds.
The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.
The device is intended for single patient, one time use only.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Millican
(Division Sign-Of estorative.
510(k) Number K082103
LifaCell LTM Wound Dressing 510(k) Page 12 of 68
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