(25 days)
HYALOMATRIX® is indicated for the management of wounds including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
HYALOMATRIX is a bilayered, sterile, flexible, and conformable wound dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth.
The provided text describes a 510(k) submission for the HYALOMATRIX® wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or a "performance study" in the traditional sense (e.g., a clinical trial with predefined endpoints and statistical analysis) are described in the provided text. The submission primarily relies on biocompatibility testing and the assertion that "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device."
The closest approximations to "reported performance" are the general statements related to biocompatibility:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | HYAFF 11 (Drug Component) |
| Cytotoxicity | Neither cytogenic |
| Hemolysis | Not hemolytic |
| Acute Oral Toxicity | LD50 > 5,000 mg/kg |
| Acute Dermal Toxicity | LD50 > 2,000 mg/kg |
| Ocular Irritation | Not an ocular irritant |
| Dermal Irritation | Not a dermal irritant |
| Sensitization | Lack of sensitizing effect |
| Genotoxicity | No evidence of genotoxicity |
| Implantation (up to 1 year) | No treatment-related toxicity; degraded within 4 months |
| Pyrogenicity (LAL test) | Endotoxin levels within specification (≤0.2 EU/mg) |
| USP XXII (Plastic Containers tests) | No toxicity observed; no effect of leachables on safety |
| Silastic® Medical Adhesive Silicone, Type A (Component) | |
| Cytotoxicity | Cytotoxic effects in multiple cell culture assays (direct contact and extracts) |
| Pyrogenicity | Negative |
| U.S.P. Class V | Negative |
| Hemolysis | Negative |
| Implantation (90-day) | No noteworthy histological findings |
| Skin Sensitization | No skin sensitization response |
| Loctite cured film (Component) | |
| Intracutaneous Irritation | Non-irritating |
| Acute Toxicity | Not acutely toxic |
| Cytotoxicity | Non-cytotoxic |
| Hemocompatibility | Hemocompatible |
| Hemolysis | Non-hemolytic |
| Implantation | No treatment-related histopathological findings |
| U.S.P. Physicochemical tests | Passed |
| Overall Device (HYALOMATRIX®) | |
| Safety & Effectiveness | Supported by clinical experience (no specific data provided) |
Important Note: The "Cytotoxicity" for the Silastic® component is listed as having "cytotoxic effects." This is a critical finding, and it's unusual for a component description to include such a negative result without further context or mitigation strategies. However, the subsequent findings for "Loctite cured film" and the overall conclusion suggest that this might have been related to raw material testing or specific extraction methods, and the final device's performance was considered acceptable for its intended use. Without more detail, it's hard to interpret fully.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission does not describe a specific "test set" in the context of a clinical performance study with a predefined sample size of wounds or patients. The biocompatibility tests used animal models (e.g., guinea pigs for sensitization), in vitro cell cultures, and chemical analyses, but specific sample sizes for these individual tests are not detailed in the summary.
- Data Provenance: The biocompatibility data is likely from laboratory studies (in vitro and in vivo animal models). There is no mention of country of origin for this data or whether it was retrospective or prospective. The statement "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device" vaguely implies real-world usage but provides no specifics on the data source, size, or methodology.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as there was no comparative clinical performance study described that would require expert adjudication of results (e.g., wound healing assessment by multiple clinicians). Biocompatibility tests rely on established scientific methods and laboratory protocols rather than expert consensus on a 'ground truth'.
4. Adjudication Method for the Test Set
Not applicable. Since no specific test set or clinical performance study requiring human assessment is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. There is no mention of an MRMC study or any comparative effectiveness study involving human readers with or without AI assistance. This device is a wound dressing, not an imaging or diagnostic AI-powered device.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant or described.
7. Type of Ground Truth Used
The "ground truth" in this context is derived from:
- Biocompatibility test results: These are objective measurements and observations from standardized in vitro and in vivo (animal) tests (e.g., cell viability, hemolytic index, irritation scores, histological findings).
- Clinical experience: While not explicitly detailed, the reference to "clinical experience" implies that observing actual patient outcomes with the device in practice forms a qualitative basis for safety and effectiveness, but it is not quantified as a "ground truth" through a rigorous study.
8. Sample Size for the Training Set
Not applicable. As this is a medical device (wound dressing) and not an AI/algorithm-based diagnostic or imaging tool, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.
In summary: The provided 510(k) summary for HYALOMATRIX® focuses on demonstrating substantial equivalence primarily through detailed biocompatibility testing of its components and a general statement about clinical experience supporting its safety and effectiveness. It does not contain information about prospective clinical trials with defined acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance studies.
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Anika Therapeutics, S.r.l.
K073251
510(k) K073251
HYALOMATRIX®
510(k) SUMMARY
DEC 1 4 2007
Anika Therapeutics, S.r.l. (former Fidia Advanced Biopolymers, S.r.l) 510(k) Owner: Via Ponte dell Fabbrica 3/B 35031 Abano Terme PADOVA, ITALY Contact: Dr. Adriano Zanotti Regulatory Affairs Phone: +39-049-82 32 650
+39-049 86 11 580
HYALOMATRIX™ KC (Laserskin) Wound Dressing
HYALOMATRIX®
Wound Dressing Product Code FRO
Unclassified
Date Summary Prepared:
May 19, 2011 Revisel
Trade Name: Common/Classification Name:
Classification:
Fax:
Predicate Devices:
Device:
K001508 Bilayer Matrix Wound Dressing Integra LifeSciences Corporation
Fidia Advanced Biopolymers S.r.l.
K021792 Oasis Wound Matrix
Cook Biotech, Inc. K061711
Device
Description:
Lateral View
matrix acts as a scaffold for cellular invasion and capillary growth. HY ALOMATRIX is indicated for the management of wounds including: Intended Use: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
HY ALOMATRIX is a bilayered, sterile, flexible, and conformable wound
dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable
Technological Similar to the predicate devices, HYALOMATRIX is a biologically-derived Characteristics: wound dressing that provides a scaffold for in-growing cells, and like the Integra Bilayer Matrix Wound Dressing, it contains a semipermeable silicone
May 19, 2011
CONFIDENTIAL
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layer to prevent moisture loss.
Biocompatibility The biocompatibility of HYAFF 11 (powder or film), one component of Data: HY ALOMATRIX, was assessed in a series of in vitro and in vivo studies.
Cytotoxicity and hemolysis studies demonstrate that HYAFF 11 films are neither cytogenic nor hemolytic. Acute oral and dermal toxicity studies on HYAFF 11 powder indicate that the lethal dose of HYAFF 11 is greater than 5,000 mg/kg and 2,000 mg/kg, respectively. Irritation studies demonstrate that HYAFF 11 powder is not an ocular or dermal irritant, and a sensitization study provides evidence for the lack of a sensitizing effect. No evidence of genotoxicity was observed in three in vitro assays or one in vivo study. An implantation study of up to 1 year found no evidence of treatment-related toxicity, and demonstrated that the HYAFF 11 film was degraded within 4 months. The Limulus Amebocyte Lysate ("LAL") test is used to assess the pyrogenicity of HYAFF 11 as part of the finished product specifications, and the endotoxin levels are within specification (≤0.2 EU/mg).
No toxicity was observed in USP XXII (Plastic Containers tests) testing, indicating that any potential leachable substances present in HYAFF 11 from the packaging used for HYALOMATRIX have no effect on the safety of this device.
Biocompatibility testing on the Silastic® Medical Adhesive Silicone, Type A included cytoxicity in multiple cell culture assays; pyrogenicity; U.S. P. Class V testing; hemolysis; 90-day implantation; and guinea pig skin sensitization. The material produced cytotoxic effects in multiple cell culture assays when placed in direct contact and when extracts of the material were tested. Pyrogenicity, U.S.P. Class V, and hemolysis assays were negative. Implantation studies with cured material resulted in no noteworthy histological findings, and saline extracts did not produce a skin sensitization response in guinea pigs.
Biocompatibility testing on the Loctite cured film included intracutaneous irritation; acute toxicity; cytotoxicity; hemocompatibility; hemolysis; implantation; and U.S.P. physicochemical tests. The material was nonirritating, not acutely toxic; non-cytotoxic; non-hemolytic; hemocompatible; produced no treatment-related histopathological findings upon implantation; and passed the U.S.P. physicochemical tests.
Performance Data:
Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device.
Conclusions:
The performance data discussed above demonstrate that the device is as safe and effective, and performs as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping figures suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 19 2011
Fidia Advanced Biopolymers S.r.l. % Morgan, Lewis & Bockius, LLP Sharon A. Segal, Ph.D. 1111 Pennsylvania Avenue, NW Washington, District of Columbia 20004
Re: K073251
Trade/Device Name: HYALOMATRIX® PA Regulation Number: Unclassified Product Code: FRO Dated (Date on orig SE ltr): November 19, 2007 Received (Date on orig SE ltr): November 26, 2007
Dear Dr. Segal:
This letter corrects our substantially equivalent letter of December 14, 2007.
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
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Page 2 - Sharon A. Segal. Ph.D.
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/ucm1118001/phm.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" (21CFFR, 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 tollofree minber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number K073251 (if known):
HYALOMATRIX ® Device Name:
HYALOMATRIX® is indicated for the management of wounds Indications for Use: including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Daniel Kromeda MXM
(Division Sign Off)
Division Sign Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K073251
N/A