(29 days)
Null
No
The device description and performance studies focus on the material properties and established clinical use of bovine pericardial patches, with no mention of AI or ML.
No
The device is a patch for surgical repair and reconstruction, not a device used for treating disease or maintaining health.
No
Explanation: The device description states it is a "patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing," which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "bovine pericardial patch," which is a physical, biological material, 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 VascuCel is used as a patch in surgical procedures (great vessel repair, peripheral vascular reconstruction, suture line buttressing). This is a therapeutic or reconstructive use, not a diagnostic one.
- Device Description: The description details a bovine pericardial patch, a material used for physical repair or support within the body. This is consistent with a surgical implant or patch, not a diagnostic reagent or instrument used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. VascuCel does not fit this description.
N/A
Intended Use / Indications for Use
VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.
Product codes
DXZ
Device Description
The VascuCel device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
great vessel, peripheral vascular
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
The safety and effectiveness of bovine pericardial patches for the reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature and is the current standard of care in clinical practice. The verification and validation testing conducted on CardioCel has demonstrated that the device is safe and effective for the proposed indication for use as a patch for peripheral vascular reconstruction and suture line buttressing. Clinical data demonstrating the acute safety of VascuCel is also provided to support the proposed specific indication.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Admedus Regen Pty Ltd % Ms. Mary Donlin Director Regulatory Affairs and Compliance Admedus Corporation 860 Blue Gentian Road, Ste 295 Eagan, Minnesota 55121
Re: K162579 Trade/Device Name: VascuCel Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate. Or Polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: September 14, 2016 Received: September 15, 2016
Dear Ms. Donlin,
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
1
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 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 vours.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162579 KHANKA
Device Name VascuCel
Indications for Use (Describe)
VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) SUMMARY of Safety and Effectiveness
(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)
I. Applicant Information:
| Date Prepared:
Submitter: | September 14, 2016
Admedus Regen Pty Ltd |
|-----------------------------------|---------------------------------------------------------------|
| Address: | 26 Harris Road
Malaga, Western Australia 6090
Australia |
| Establishment
Registration No. | 3010805634 |
| Contact Person: | Mary E. Donlin
Director Regulatory Affairs and Compliance |
| Telephone Number:
Fax Number: | (651) 493-0606 Ext 1008
(651) 528-8042 |
II. Device Information:
| Trade Name: | VascuCel™ |
|---|---|
| Common Name: | Cardiovascular Patch |
| Classification Name: | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, |
| POLYPROPYLENE | |
| Classification: | Class II, 21 CFR § 870.3470 |
| Product Code: | DXZ |
| Predicate Device: | K130872 CardioCel |
| Predicate Device | |
| Intended Use: | CardioCel is indicated for use as a patch in pericardial |
| closure and the repair of cardiac and vascular defects including | |
| intracardiac defects; septal defects, valve and annulus repair; great | |
| vessel reconstruction, peripheral vascular reconstruction and suture | |
| line buttressing. | |
| Device Description: | The VascuCel device is a bovine pericardial patch prepared from |
| glutaraldehyde-crosslinked bovine pericardium using the ADAPT® | |
| TEP technology. It is a sterile, light yellow to beige colored, | |
| moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8 | |
| cm size and a 0.8 x 8 cm size. | |
| Intended Use: | VascuCel is indicated as a patch in great vessel repair, peripheral |
| vascular reconstruction and suture line buttressing. | |
| Contraindications: | VascuCel is not designed, sold or intended for use except as |
| indicated. | |
| The use of a tissue bioprosthesis must be considered on an | |
| individual patient basis. | |
| Comparison to | |
| Predicate Device: | CardioCel was cleared by the FDA (K130872) for use as a patch in |
| pericardial closure and the repair of cardiac and vascular defects | |
| including intracardiac defects; septal defects, valve and annulus | |
| repair; great vessel reconstruction, peripheral vascular | |
| reconstruction and suture line buttressing. The additional sizes | |
| added to the existing CardioCel product line are within the current | |
| product specification range for CardioCel. The minor change to | |
| the dimensions of the device (from 5 cm x 8 cm to 2 cm x 8 cm | |
| and 0.8cm x 8 cm respectively) is also included in this submission. | |
| The purpose of the dimensional change is to manufacture a device | |
| that meets the current needs of the surgeon and to reduce the free | |
| hand trimming of the device during the surgical procedure. The | |
| primary purpose for this submission is to modify the indication for | |
| use from a general to specific indication to denote the use as a | |
| patch for great vessel reconstruction, peripheral vascular | |
| reconstruction and suture line buttressing. | |
| Test Data: | The safety and effectiveness of bovine pericardial patches for the |
| reconstruction and repair of cardiac and vascular anatomy is well | |
| established in clinical literature and is the current standard of care | |
| in clinical practice. | |
| The verification and validation testing conducted on CardioCel has | |
| demonstrated that the device is safe and effective for the proposed | |
| indication for use as a patch for peripheral vascular reconstruction | |
| and suture line buttressing. Clinical data demonstrating the acute | |
| safety of VascuCel is also provided to support the proposed | |
| specific indication. | |
| Summary: | The accumulated technical information, intended use, laboratory |
| verification tests and clinical performance data that was performed | |
| on CardioCel as provided in K130872, demonstrates that VascuCel | |
| is substantially equivalent to the currently marketed predicate | |
| device. |
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