(34 days)
No
The device description and performance studies indicate a simple mechanical sizing tool without any mention of computational analysis, algorithms, or learning capabilities.
No
The device is used to determine the size of the host vessel to select an appropriate graft, which is a diagnostic or sizing function, not a therapeutic one.
No
The device is described as an accessory to assist in determining the size of the host vessel lumen to select the appropriate vascular graft diameter, which is a measurement tool and not for diagnosing a medical condition.
No
The device description explicitly states it consists of physical, disposable sizers made of a biocompatible material, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist a physician in determining the size of a host vessel lumen to select an appropriate vascular graft. This is a surgical planning and procedural aid, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is a set of physical sizers used to measure a vessel during surgery. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
Therefore, the InterVascular InterGard Knitted Vascular Graft Sizer is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
Product codes
DSY
Device Description
The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.
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
Physician / 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)
Biocompatibility tests performed on the finished products show that the device is non-hemolytic and non-cytotoxic. In addition, extensive biocompatibility testing conducted on the material demonstrated its suitability for medical use in devices. The material tested for biological performance meets the requirements of the U.S. Pharmacopeia (USP) XXIII Class VI-50 and are compatible with blood and demonstrate no cytotoxic, mutagenic or irritant potential.
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
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
AUG 1 4 2002
510(K) SUMMARY
InterVascular InterGard Knitted Vascular Graft Sizer Trade Name: Common Name: Vascular Graft Sizer
The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.
The InterVascular Graft Sizer is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
Biocompatibility tests performed on the finished products show that the device is non-hemolytic and non-cytotoxic. In addition, extensive biocompatibility testing conducted on the material demonstrated its suitability for medical use in devices. The material tested for biological performance meets the requirements of the U.S. Pharmacopeia (USP) XXIII Class VI-50 and are compatible with blood and demonstrate no cytotoxic, mutagenic or irritant potential.
InterVascular considers that this device is substantially equivalent in intended use, composition and function to the predicate device, Meadox Graft Sizer manufactured by Meadox Medical Inc. The Meadox Graft Sizer received premarket clearance on May 7, 1986 under 510(k) K854431.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
AUG 1 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
InterVascular c/o Ms. Amy Aulwes Director, Regulatory Affairs Health Policy Associates, Inc. 20 Walnut Street, Suite 12 Wellesley, MA 02481
Re: K022242
Trade Name: InterVascular InterGard Knitted Vascular Graft Sizer Regulation Number: 21 CFR 870.3460 Regulation Name: Accessory to Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: July 9, 2002 Received: July 11, 2002
Dear Ms. Aulwes:
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 such 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 mav publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Amy Aulwes .
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Thosad Oth for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PRODUCT INDICATIONS FOR USE
(Page 1 of 1)
Kozzy2
510(k) Number:
Device Names:
InterVascular InterGard Knitted Vascular Graft Sizer
Indications for Use:
InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use __
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices
510(k) Number K022242
8/14/02