(64 days)
Not Found
No
The device description and intended use focus on mechanical tools (sheaths and snares) for dilation and retrieval, with no mention of AI/ML or related technologies.
No
The device descriptions and intended uses focus on mechanical actions like dilation and retrieval, not a therapeutic effect on a disease or condition.
No
The devices described are intended for "percutaneous dilation of tissue" or "percutaneous retrieval" of objects, which are interventional or therapeutic procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states the devices consist of "sheaths and snares," which are physical hardware components, 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 describes procedures performed on a patient (percutaneous dilation and retrieval of objects within the body). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a patient's health.
- Device Description: The device description confirms that these are physical tools (sheaths and snares) used for procedures within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
GCC, DRE, DXE
Device Description
The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and/or in patients requiring the retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
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
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.
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
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
510(k) Premarket Notification: COOK Vascular™, Incorporated Intravascular Retrieval Devices March 20, 1998
MAY 2 6 1998
510(K) SUMMARY
March 20, 1998
98106/
Submitted By:
Neal Fearnot, Ph.D. President MED Institute, Incorporated 1400 Cumberland Ave. West Lafayette, IN 47906
| Device Name | DC# |
|---|---|
| Byrd Dilator Sheath Set - Polypropylene | K893480 |
| Byrd Dilator Sheath Set - Teflon | K902469 |
| Byrd Stainless Steel Dilator Sheath | K902502 |
| Byrd Workstation | K902477 |
| K914555 | |
| Byrd Telescoping Stainless Steel Dilator Sheath Set | K922354 |
| Needle's Eye Snare | K961992 |
Device Description and Intended Use: The devices consist of sheaths and snares Device Description and Intended OSC. The percutaneous dilation of tissue surrounding the intended for use in patiens requiring the percents on and/or in patients requiring the first cardiac leads, indwelling catheters, and releign organisms of catheter tubing or wire guides, and other foreign objects.
| Predicate Devices | DC# |
|---|---|
| Metal Reinforced Flexible Dilator Sheath | K945586 |
| Wilkoff Locking Stylet | K970690 |
Substantial Equivalence: The 510(k) submission serves to notify FDA of labeling Substantial Equivalence. " The STQ(x) backings have been made to the devices;
revisions made to previously cleared devices. No changes the seme intended use they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1998
Neal Fearnot, Ph.D. President MED Institute, Inc. A Cook Group Company P.O. Box 2402 West Lafayette, IN 47906 Re: K981061 Trade Name: Byrd Dilator Sheath Set-Polypropylene Regulatory Class: II Product Code: GCC Byrd Dilator Sheath Set-Teflon Trade Name: Regulatory Class: II Product Code: GCC Byrd Stainless Steel Dilator Sheath Trade Name: Requlatory Class: II Product Code: DRE . Workstation Intravascular Retrieval Set Trade Name: Regulatory Class: II Product Code: DRE Byrd Telescoping Stainless Steel Dilator Trade Name: Sheath Set Requlatory Class: II Product Code: GCC
Needle's Eye Snare Trade Name: Regulatory Class: II Product Code: DXE Dated: March 20, 1998 Received: March 23, 1998
Dear Dr. Fearnot:
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
2
Page 2 - Dr. Neal Fearnot
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 against 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.
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 regulation (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 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97).
3
Page 3 - Dr. Neal Fearnot
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. Callahan
Thomas J. Ca lahan, Ph.D. Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Byrd Dilator Sheath Set - Polypropylene or Teflon Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Byrd Stainless Steel Dilator Sheath Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Byrd WORK STATION™ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
Byrd Telescoping Stainless Steel Dilator Sheath Set Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)