(84 days)
Not Found
Not Found
No
The summary describes a mechanical device for removing objects with a central lumen and makes no mention of AI or ML.
No
The device is used for the removal of objects from the body, which is a procedural/surgical function, not a therapeutic treatment of a disease or condition.
No
The device description indicates it is used for percutaneous removal of objects, which is a therapeutic or interventional procedure, not a diagnostic one.
No
The device description clearly states it is a physical, sterile, single-use device used for percutaneous removal of objects, indicating it is a hardware device.
Based on the provided information, the Locking Stylet 2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the percutaneous removal of medical devices from the body. This is a surgical/interventional procedure, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the physical device used for removal, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health.
Therefore, the Locking Stylet 2 is a medical device used for a therapeutic/interventional purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.
Product codes
DQX
Device Description
The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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.)
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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.
The Locking Stylet 2 is similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation.
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
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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510(k) Premarket Notification Locking Stylet 2
MAY 2 0 1997
510(K) SUMMARY I.
Submitted By:
Neal E. Fearnot, Ph.D., E.E. President MED Institute, Incorporated P.O. Box 2402 West Lafavette, IN 47906 (317) 463-7537 February 24, 1997
Device:
| Trade Name: | Locking Stylet 2 |
|---|---|
| Common/Usual Name: | Stylet, Wire Guide Stylet, Catheter Retrieval |
| Device | |
| Proposed Classification Name: | Predicate devices of this type with similar |
| intended uses have been classified into Class I or | |
| Class II. |
Predicate Devices:
The Locking Stylet 2 is similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation.
Device Description:
The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.
Substantial Equivalence:
The Locking Stylet 2 will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK Vascular™ Incorporated. This device is similar with respect to indications for use, materials, and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
1
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Neal E. Fearnot, Ph.D. President MED Institute, Inc. A Cook Group Company 1400 Cumberland Avenue West Lafayette, Indiana 47906
Re: K970690 Locking Stylet 2 II (two) Requlatory Class: Product Code: DQX Dated: February 24, 1997 February 25, 1997 Received:
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 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
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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 w 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 diaqnostic 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" (21 CFR 807.97). Other qeneral 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:Locking_Stylet_2____________________________________________________________________________________________________________________________________________
Indications For Use:
The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORE &ffige of Device Evaluation (ODE)
Tiafik
(Division Sign-Off)
Division of General Restorative Dev 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)