(273 days)
No
The document describes a biological material (fish skin) used as a staple line buttress and its performance in bench and animal studies. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a prosthesis for staple line reinforcement in surgical repair of soft tissue deficiencies, and its function involves physically buttressing staple lines. It is not intended to treat or cure a disease or condition, but rather to aid in surgical repair.
No
Explanation: The device is described as a prosthesis for staple line reinforcement in surgical repair, not for diagnosing conditions. It is used during surgical procedures to strengthen tissue.
No
The device description clearly states the device is formed of "intact acellular fish skin" and is a physical buttress material supplied in sterile packaging. This indicates it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a prosthesis for surgical repair of soft tissue deficiencies and reinforcement of staple lines during various surgical procedures. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is a physical material (acellular fish skin) used as a buttress during surgery. It does not involve testing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the mechanical strength, usability in a surgical setting, and the effectiveness of the staple line reinforcement (leakage, burst pressure). These are all related to the device's function during surgery, not its diagnostic capabilities.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.
Kerecis SecureMesh can be used for reinforcement of staple lines during:
- Bariatric surgical procedures
- Colorectal and Colon surgical procedures
- Gastric, small bowels and mesentery procedures
- Lung and bronchus resections
Product codes
OXE
Device Description
Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.
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
healthcare professional, in the operating theatre
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
7.1 BENCH TESTING
The Supporting Predicate, MariGen Wound (K132343) has undergone appropriate biocompatibility testing and viral-inactivation evaluation. The information provided demonstrate that the device is biocompatible and that viral risks are not present. The Subject Device, (K153364) and the Supporting Predicate, MariGen Wound (K132343) utilize the same raw materials (fish skin), processing components/solutions and manufacturing processes, and are identical. Therefore, no further biocompatibility testing or anti-viral considerations were made.
The Subject Device is substantially equivalent to the Primary Predicate in terms of physical characteristics and tests results. The following tests have been performed to substantiate the equivalence.
- Tensile strength: A Uniaxial strength test was performed to compare the tensile strength of the product and the predicate.
- Usability: Loading time, Transfer of buttress to stapler, Ease of Use, Force to fire and Slippage.
- Performance: Leak at Staple line, Leak Pressure and Seal burst.
7.2 ANIMAL STUDIES
An acute porcine ex-vivo study was performed on the Subject Device and Peri-Strips Dry Staple Line Reinforcement (K040415) to support substantial equivalence. Peri-Strips Dry Staple Line Reinforcement (K040415) is the Predicate Device for the Veritas Dry Collagen Matrix (K041669) and the two materials are identical, from the material source, with the same treatment indications as well as mechanical and clinical properties. Comparison with un-buttressed stapling was also undertaken (negative control).
There was no significant difference between the Subject Device and the Primary Predicate. The Subject Device technological and physical characteristics are equivalent to the Predicate Device.
7.3 CLINICAL STUDIES
No clinical testing was included in this submission
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's mission of promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2016
Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 Isafjordur, 400 Iceland
Re: K153364
Trade/Device Name: Kerecis SecureMesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXE Dated: July 15, 2016 Received: July 21, 2016
Dear Gudmundur Sigurjonsson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153364
Device Name
Kerecis SecureMesh
Indications for Use (Describe)
Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.
Kerecis SecureMesh can be used for reinforcement of staple lines during:
- Bariatric surgical procedures
- Colorectal and Colon surgical procedures
- Gastric, small bowels and mesentery procedures
- Lung and bronchus resections
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510k Summary
SUBMITTER/510K HOLDER 1
| Address: | Kerecis Limited
Eyrargata 2
400 Isafjordur
Iceland |
|-----------------|-------------------------------------------------------------|
| Contact Person: | Gudmundur Fertram Sigurjonsson
Executive Chairman |
| Telephone: | 011 354 562 2601 |
| Date Prepared: | November 9th, 2015 |
2 DEVICE NAME
| Proprietary Name: | Kerecis SecureMes |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical |
| Classification Product Code: | OXE |
| Regulatory Number: | 878.3300 |
3 PREDICATE DEVICES
- Veritas Dry Collagen Matrix (K041669)- PrimaryPredicate
- . MariGen Wound (K132343) - Supporting Predicate
DEVICE DESCRIPTION বা
Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.
4
INTENDED USE ഗ
Subject Device is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.
Subject Device can be used for reinforcement of staple lines during:
- . Bariatric surgical procedures
- . Colo-rectal and colon surgical procedures
- . Gastric, small bowels and mesentery procedures
- Lung, and bronchus resections
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6 PREDICATE DEVICES
Subject Device is substantially equivalent to the Primary Predicate, where the intended use and indication list of the Subject Device falls within the intended use and indication list of the Primary Predicate.
The Subject Device, and the Supporting Predicate, both are fish skin sheets that have been decellularized and lyophilized. Both devices consist of a terminally sterilized sheet of the provided in prescribed size configuration and thicknesses. Both are packaged in a pouch configuration.
| 510(k) | Subject Device K153364 | Primary Predicate
(K041669) |
|---------------|--------------------------------------------------|--------------------------------------------------|
| Device name | Kerecis SecureMesh | Veritas Dry Collagen Matrix |
| Product Codes | OXE | FTM |
| Intended use | Intended to be used as a staple
line buttress | Intended to be used as a staple
line buttress |
| Indications | Reinforcement of staple lines
during | Reinforcement of staple lines
during |
| 1 | Bariatric surgical procedures | Bariatric surgical procedures |
5
| 2 | Gastric, small bowels and
mesentery procedures | Gastric, small bowel, mesentery |
|---------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| 3 | Colorectal and colon procedures | Colon and colorectal procedures |
| 4 | Lung, and bronchus resections | Lung and bronchus resections |
| 5 | Not claimed | Occlusion of the left atrial
appendage during open chest
procedures during cardiac |
| Animal Origin | Atlantic Cod Fish | Bovine |
| Tissue type | Skin | Pericardium |
| Presentation | A delivery system with an
absorbable buttress
(dehydrated, non-cross- linked | A delivery system with a
buttress (comprised of
dehydrated, non-cross- linked |
Table 1 Comparing the predicate device and subject device Intended Use and Indication for Use. The the underlying functional design and principles of operation
PERFORMANCE 7
7.1 BENCH TESTING
The Supporting Predicate, MariGen Wound (K132343) has undergone appropriate biocompatibility testing and viral-inactivation evaluation. The information provided demonstrate that the device is biocompatible and that viral risks are not present. The Subject Device, (K153364) and the Supporting Predicate, MariGen Wound (K132343) utilize the same raw materials (fish skin), processing components/solutions and manufacturing processes, and are identical. Therefore, no further biocompatibility testing or anti-viral considerations were made.
The Subject Device is substantially equivalent to the Primary Predicate in terms of physical characteristics and tests results. The following tests have been performed to substantiate the equivalence.
| 510(k) | Subject Device K153364 |
|---|---|
| Device name | Kerecis SecureMesh |
| Tensile strength | A Uniaxial strength test was performed to compare the tensile strength of the |
| product and the predicate |
6
| Usability | Loading time, Transfer of buttress to stapler, Ease of Use, Force to fire and
Slippage |
|-------------|-------------------------------------------------------------------------------------------|
| Performance | Leak at Staple line, Leak Pressure and Seal burst |
Table 2 - Subject Device Bench testing
7.2 ANIMAL STUDIES
An acute porcine ex-vivo study was performed on the Subject Device and Peri-Strips Dry Staple Line Reinforcement (K040415) to support substantial equivalence. Peri-Strips Dry Staple Line Reinforcement (K040415) is the Predicate Device for the Veritas Dry Collagen Matrix (K041669) and the two materials are identical, from the material source, with the same treatment indications as well as mechanical and clinical properties. Comparison with un-buttressed stapling was also undertaken (negative control).
There was no significant difference between the Subject Device and the Primary Predicate. The Subject Device technological and physical characteristics are equivalent to the Predicate Device.
7.3 CLINICAL STUDIES
No clinical testing was included in this submission
CONCLUSION 8
The subject device, Kereis SecureMesh, meets the requirements to perform its intended use as a staple line sealer and is substantially equivalent to the legally marketed predicate device, Veritas Dry Collagen Matrix (K041669).