(24 days)
Kelly-Wick Tunneler
Not Found
No
The device description and intended use describe a purely mechanical surgical instrument. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is used for creating tunnels during surgical procedures, which is an interventional/surgical tool rather than a therapeutic one designed to treat a condition.
No
The device is described as a surgical tool for creating tunnels for the placement of vascular prostheses or grafts, not for diagnosing conditions.
No
The device description clearly states it is a stainless steel device with physical components like a handle, shafts, and tips, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bi-Directional Tunneler is a surgical instrument used to create physical tunnels within the body for the placement of grafts. It is used during a surgical procedure on the patient, not for analyzing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Bi-Directional Tunneler is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
Product codes (comma separated list FDA assigned to the subject device)
74 DSY
Device Description
The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment.
The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tunnels
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kelly-Wick Tunneler
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
4/22/99
IMPRA
f
A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: 800-321-4254 602-894-9515 FAX: 602-966-7062
510(k) Premarket Notification Bi-Directional Tunneler
510(k) SUMMARY
A. Submitter Information
| Submitter's Name: | IMPRA, Inc. |
|---|---|
| A Subsidiary of C. R. Bard, Inc. | |
| Address: | 1625 West Third Street |
| Tempe, Arizona 85281 | |
| Telephone: | (480) 894-9515 |
| Fax: | (480) 966-7062 |
| Contact Person: | Kristi M. Kistner |
| Manager, Regulatory Affairs | |
| Date of Preparation: | March 26, 1999 |
B. Device Name
| Trade Name: | Bi-Directional Tunneler |
|---|---|
| Common/Usual Name: | Vascular Tunneler |
| Classification Name: | An accessory to a vascular graft prosthesis |
C. Predicate Device Name
Trade Name(s):
Kelly-Wick Tunneler
IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\TUNNELER\Tun510k.wpd22
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000027
1
Device Description D.
The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment.
The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.
E. Intended Use
The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
F. Technological Characteristics Summary
The Bi-Directional Tunneler has the same indications for use as the predicate device. All components for both the Bi-Directional Tunneler and the predicate device are made from stainless steel, are equivalent in size and configuration, and are provided non-sterile to the user. The only significant difference between the Bi-Directional Tunneler and the Kelly-Wick Tunneler is the bi-directional feature. This bi-directionality is a change in the operating principle of the tunneler and does not affect safety or effectiveness of the device.
G. Summary of Substantial Equivalence
The Bi-Directional Tunneler is substantially equivalent in intended use, design, technology/operating principles, materials and performance to the Kelly-Wick Tunneler. Differences between the two devices do not raise any significant issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular arrangement of text surrounding a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The symbol in the center appears to be three abstract human profiles connected by a flowing line, possibly representing interconnectedness or the provision of services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1999
Ms. Kristi Kistner IMPRA, Inc. A Subsidiary of C.R. Bard, Inc. P.O. Box 1740 Tempe, AZ 85280-1740
Re: K991027 Impra Bi-Directional Tunneler Requlatory Class: II (Two) Product Code: 74 DSY Dated: March 26, 1999 Received: March 29, 1999
Dear Ms. Kistner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Paqe 2 - Ms. Kristi Kistner
This letter will allow you to begin marketing your device as described in your 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 you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__1__of__1__
510(k) Number (if known): __ K991027_
Device Name:__ Impra Bi-Directional Tunneler
Indications For Use: The Bi-Driectional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autologous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beebe & Temple Co.
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K99 1027
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)