(112 days)
CollaSorb™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers .
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
CollaSorb™ wound dressing is a wound care product composed of a native collagen and calcium-alginate, which comes as a sterile, non-pyrogenic product for single use in a single pouch package.
CollaSorb 10 wound dressings are pliable, absorbent dressings that absorb moisture such as wound fluid by forming a soft, conformable moist gel sheet at the wound surface and thus maintaining a moist environment. Due to its excellent wet stability and elasticity the CollaSorb 100 wound dressing can easily be applied and fitted to the wounds and is also for the management of deep wounds.
The provided text describes a 510(k) submission for the CollaSorb Collagen Wound Dressing. A 510(k) submission is a premarket notification demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not involve explicit acceptance criteria and a detailed study proving performance against those criteria in the same way a PMA (Premarket Approval) would.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use as a legally marketed device and the same technological characteristics, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate device.
Therefore, the information I can extract will be based on the comparison of the proposed device (CollaSorb™) to its predicate device (ColActive™), rather than a study with pre-defined acceptance criteria and performance metrics.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, there are no "acceptance criteria" presented in the traditional sense of a clinical trial or performance study with numerical targets. Instead, the "acceptance criteria" are implied by the comparison to the predicate device, where the new device must be equally safe and effective. The "reported device performance" is the demonstration that the CollaSorb™ device shares similar technical characteristics and intended uses with the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported CollaSorb™ Performance |
|---|---|---|
| Indications for Use | Must be same as predicate: Management of full and partial thickness wounds including:- Pressure ulcers- Venous ulcers- Diabetic ulcers- Ulcers caused by mixed vascular etiologies- Second degree burns- Donor and graft sites- Abrasions- Dehisced surgical wounds- Traumatic wounds healing by secondary intention | Meets Predicate:- Pressure ulcers- Venous ulcers- Diabetic ulcers- Ulcers caused by mixed vascular etiologies- Second degree burns- Donor and graft sites- Abrasions- Dehisced surgical wounds- Traumatic wounds healing by secondary intention |
| Material | Collagen / Sodium-Alginate (Predicate) | Differs Slightly: Collagen / Calcium-Alginate (but deemed substantially equivalent) |
| Biodegradable | Yes | Meets Predicate: Yes |
| Biocompatibility | In accordance with ISO 10993-1 | Meets Predicate: In accordance with ISO 10993-1 |
| Sterile | Yes - gamma radiation | Meets Predicate: Yes - gamma radiation |
| Sizes | 2 in x 2 in ($25 cm^2$), 4 in x 4 in ($100 cm^2$) | Meets Predicate: 2 in x 2 in ($25 cm^2$), 4 in x 4 in ($100 cm^2$) |
| Non-Pyrogenic | (Not explicitly stated for predicate in table, but implied good manufacturing practice) | Demonstrated: Yes (rabbit pyrogen test) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a "test set" in the context of clinical data for performance evaluation. The submission relies on a comparison of technical characteristics and intended use to a predicate device. Thus, there were no clinical studies with a specific sample size, data provenance, or study design (retrospective/prospective) presented in this 510(k) summary for the CollaSorb™ device's performance against explicit criteria. The "rabbit pyrogen test" is mentioned for non-pyrogenicity, which is a laboratory test, not a clinical study on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving expert readers or ground truth establishment in a diagnostic or clinical efficacy context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 device is a collagen wound dressing, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The substantial equivalence is based on technical characteristics and intended use, not on clinical ground truth in a study dataset.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an algorithm-based device.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
510(k) Summary 807.92(c)
HARTMANN-CONCO Inc.
1/2
SPONSOR
Company Name:
807.92(a)(1)
| Company Address: | 481 Lakeshore ParkwayRock Hill, SC 29730 |
|---|---|
| ------------------ | ---------------------------------------------- |
AUG 2 6 2009
510(k) #
| Telephone: | 803-325-7600 |
|---|---|
| Fax: | 803-325-7606 |
Scott Cost Contact Person:
Summary Preparation Date: March 2, 2009
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:
807.92(a)(2) CollaSorbTM Collagen Wound Dressing Collagen Wound Dressing Dressing, Wound, Collagen Unclassified KGN Unclassified
PREDICATE DEVICE
807.92(a)(3)
Legally Marketed Equivalent Device Product Company Colactive Collagen Wound Dressing Covalon Technologies, Inc.
DEVICE DESCRIPTION
807.92(a)(4)
CollaSorb™ wound dressing is a wound care product composed of a native collagen and calcium-alginate, which comes as a sterile, non-pyrogenic product for single use in a single pouch package.
CollaSorb 10 wound dressings are pliable, absorbent dressings that absorb moisture such as wound fluid by forming a soft, conformable moist gel sheet at the wound surface and thus maintaining a moist environment. Due to its excellent wet stability and elasticity the CollaSorb 100 wound dressing can easily be applied and fitted to the wounds and is also for the management of deep wounds.
{1}------------------------------------------------
1091338
2/2
807.92(a)(5)
DEVICE INTENDED USE
CollaSorb™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers ●
- Diabetic ulcers .
- Ulcers caused by mixed vascular etiologies .
- Venous ulcers .
- Second degree burns .
- Donor and graft sites .
- . Abrasions
- Dehisced surgical wounds .
- Traumatic wounds healing by secondary intention .
| COMPARISON OF TECHNICAL CHARACTERISTICS | 807.92(a)(6) | |
|---|---|---|
| Device Name | CollaSorbTM | ColActiveTM |
| Indications for use | - Pressure ulcers- Venous ulcers- Diabetic ulcers- Ulcers caused by mixed vascularetiologies- Second degree burns- Donor and graft sites- Abrasions- Dehisced surgical wounds- Traumatic wounds healing bysecondary intention | - Pressure ulcers- Venous ulcers- Diabetic ulcers- Ulcers caused by mixed vascularetiologies- Second degree burns- Donor and graft sites- Abrasions- Dehisced surgical wounds- Traumatic wounds healing bysecondary intention |
| Material | Collagen / Calcium-Alginate | Collagen / Sodium-Alginate |
| Biodegradable | Yes | Yes |
| Biocompatibility | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 |
| Non-Pyrogenic | Yes (rabbit pyrogen test) | - |
| Sterile | Yes - gamma radiation | Yes - gamma radiation |
| Size | 2 in x 2 in (5 cm x 5 cm = $25 cm^2$ )4 in x 4 in (10 cm x 10 cm = $100 cm^2$ ) | 2 in x 2 in (5 cm x 5 cm = $25 cm^2$ )4 in x 4 in (10 cm x 10 cm = $100 cm^2$ ) |
CONSULTAT, CULADA CIDINDICTI CO
{2}------------------------------------------------
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 features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 6 2009
Hartman-Conco Inc. % Smith Associates Mr. E.J. Smith 1468 Harwell Avenue Crofton, Maryland 21114
Re: K091338
Trade/Device Name: CollaSorb Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 3, 2009 Received: August 5, 2009
Dear Mr. Smith:
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 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. E.J. Smith
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/CDRH0ffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
y yours,
. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K0913358
Indications for Use
510(k) Number (if known):
Device Name: CollaSorb Collagen Wound Dressing
Indications for Use:
11 2
CollaSorb™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers .
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane for MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page of
510(k) Number K091338
N/A