(239 days)
Not Found
No
The summary describes a biological implant (decellularized equine pericardium) and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is intended for implantation to reinforce soft tissue, including repair of defects, hernias, and tendon repair surgery, which are therapeutic interventions.
No
The device is a surgical mesh intended for implantation to reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states it is a "decellularized equine pericardium," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "implantation to reinforce soft tissue" and "reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery." This describes a device used in vivo (within the body) for structural support and reinforcement during surgical procedures.
- Device Description: The description details a "decellularized equine pericardium" that is implanted. This is a biological material intended for surgical implantation, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is a surgical implant used to reinforce tissue during surgery.
N/A
Intended Use / Indications for Use
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
OrthADAPT® is intended for one-time use only.
Product codes
OWY, FTM, OXB, OXE
Device Description
The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic wall, muscle flap, hernias, soft tissue, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The results of biocompatibility and performance testing demonstrate that OrthADAPT is comparable to the predicate devices.
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
§ 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
Synovis Orthopedic and Woundcare, Inc.
OrthADAPT® F
510(k) Summary
Submitter Information 1
| A. | Company Name: | Synovis Orthopedic and Woundcare, Inc. |
|---|---|---|
| B. | Company Address: | 6 Jenner, Suite 150 |
| Irvine, CA 92618 | ||
| C. | Company Phone: | (949) 502-3240 |
| D. | Company Facsimile: | (949) 502-3241 |
| E. | Contact Person: | Amy Boucly |
| Manager, Regulatory Affairs/Quality Assurance | ||
| F. | Date: | 06/25/12 |
Device Identification 2
| A. | Device Trade Name: | OrthADAPT® Bioimplant |
|---|---|---|
| B. | Common Name: | Surgical Mesh |
| C. | Classification Name(s): | Surgical Mesh |
| D. | Classification Regulation: | 21 CFR 878.3300 |
| E. | Device Class: | Class II |
| F. | Device Code(s): | OWY, FTM |
| G. | Advisory Panel: | General and Plastic Surgery |
Identification of Predicate Devices 3
The OrthADAPT Bioimplant is substantially equivalent to the Fortaflex Surgical Mesh manufactured by Organogenesis, Inc. (K020049), and Depuy Restore Orthobiologic Soft Tissue Implant, manufactured by Depuy Orthopedic, Inc. (K001738).
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Synovis Orthopedic and Woundcare, Inc.
K043388 page
2/2
OrthADAPTO® FX, PX, MX
র্ব Device Description
The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
5 Indications for Use
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
OrthADAPT® is intended for one-time use only.
Substantial Equivalence ਉ
The OrthADAPT is comparable to the predicate devices in terms of intended use, technology and performance: It is similar to the predicate devices in that it has the same intended use of soft tissue reinforcement, is a collagen mesh and is similar in design and materials. The results of biocompatibility and performance testing demonstrate that OrthADAPT is comparable to 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 features a stylized depiction of a human figure in blue, with three overlapping profiles suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pegasus Biologics, Incorporated % Mr. Muir S. Meinhold Director. Regulatory Affairs. Quality Assurance 10 Pasteur, Suite 150 Irvine, California 92618
AUG 2 7 2012
Re: K043388
Trade/Device Name: Pegasus Biologics OrthADAPT™ FX,PX.MX Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM. OXB. OXE. OWY Dated: June 17, 2005 Received: June 20, 2005
Dear Mr. Meinhold:
This letter corrects our substantially equivalent letter of August 5, 2005.
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 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.
3
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/ReportalProblem/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 yours.
Mark Melkerson Director
Division of Surgical. Orthopedics and Restorative Devices Office of Device Evaluation Center for Device and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K043388
Device Name:
OrthADAPT® FX, PX, MX
Indications For Use:
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar. Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
OrthADAPT® is intended for one-time use only.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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 Keane for MM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K043388
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