(150 days)
Not Found
No
The document describes a physical guiding catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a guide catheter that provides a pathway for the introduction of therapeutic devices, but it is not a therapeutic device itself.
No
The device is described as a 'guide catheter' that provides a pathway for the introduction of biopsy devices and therapeutic devices, which are not diagnostic functions.
No
The device description clearly outlines a physical catheter with specific construction materials and components, 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 clearly states that the device provides a pathway for the introduction of therapeutic devices, specifically biopsy devices. It is used for percutaneous introduction into the body (coronary or peripheral system, right ventricle of the heart).
- Device Description: The description details the physical construction of a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to facilitate a procedure within the body.
N/A
Intended Use / Indications for Use
The Medtronic 7F and 8F Launcher Biopsy guide Catheters provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used to for the percutaneous introduction of biopsy devices.
Medtronic Launcher Biopsy Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. This includes the introduction of biopsy forcep devices. The guiding catheter is intended to be used in accessing the coronary or peripheral system.
The Medtronic 7F and 8F Launcher Right Ventricular Biopsy Guiding Catheters are intended to be used for the percutaneous introduction of biopsy forceps into the right ventricle of the heart.
Product codes
DQY
Device Description
Medtronic® 7F and 8F Launcher Biopsy Guide Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral system, right ventricle of the heart
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)
Results of testing verified that the Medtronic Launcher Biopsy Guide Catheters meet all applicable standards and specifications and are deemed adequate for the intended use.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
JUL 3 1 2003
| VI. | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Pursuant to Section 12, Safe Medical Devices Act of 1990) | |
|-----|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. | Submitter Information: | |
| | Name: | Medtronic, Inc. |
| | Address: | 37A Cherry Hill Drive, Danvers, MA 01923 |
| | Phone: | 978-777-0042 |
| | Fax: | 978-777-0390 |
| | Contact Person: | Fred Boucher, Regulatory Affairs Manager |
| | Date of Preparation: | February 28, 2003 |
| B. | Device Name: | |
| | Trade Name: | Medtronic® 7F and 8F Launcher Biopsy Guide
Catheter |
| | Common Name: | Guide Catheter |
| | Classification Name: | Intravascular Catheter / Percutaneous Catheter |
| C. | Predicate Device Names | Medtronic® 7F and 8F Launcher Guide Catheters
Medtronic SHERPA II (Vector)Guide Catheters |
| D. | Device Description: | Medtronic® 7F and 8F Launcher Biopsy Guide
Catheter |
| E. | Intended Use | The Medtronic 7F and 8F Launcher Biopsy guide
Catheters provide a pathway through which therapeuti
devices are introduced. The guiding catheter is
intended to be used to for the percutaneous
introduction of biopsy devices. |
F. Technological Characteristics Summary
- 1 . The Medtronic 7F and 8F Launcher Biopsy Guide Catheters are identical to the Medtronic 7F and 8F Launcher Guide Catheters regarding materials, components, design, packaging and sterilization.
- The indications for use are identical to the Medtronic SHERPA II 2. (commercialized as Vector) regarding the percutaneous introduction of biopsy forceps and the Medtronic Launcher Guide Catheters regarding coronary and peripheral access. They are all indicated to provide a pathway through which therapeutic devices are introduced. The Medtronic Launcher Biopsy Guide Catheter indications for use are as follows:
1
Medtronic Launcher Biopsy Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. This includes the introduction of biopsy forcep devices. The guiding catheter is intended to be used in accessing the coronary or peripheral system.
-
- Similar to the Medtronic Launcher Guide Catheters the Medtronic Launcher Biopsy Catheters will be available in 7F and 8F sizes. Similar to the Medtronic SHERPA II (Vector) Biopsy Guide Catheters, the Medtronic Launcher Biopsy Catheters will be available in one specific curve style.
-
- The Medtronic® Launcher Biopsy Guide Catheters are constructed with a braided proximal shaft with an inner liner a secondary segment (8F only), primary segment, a sleeve and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating.
- న. All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic Launcher Biopsy Guide Catheter.
-
- Results of testing verified that the Medtronic Launcher Biopsy Guide Catheters meet all applicable standards and specifications and are deemed adequate for the intended use. The guide catheters are considered to be substantially equivalent to the following device:
2
Public Health Service
Image /page/2/Picture/2 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2003
Medtronic, Inc. c/o Mr. Fred Boucher Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923
Re: K030671
Medtronic® 7F and 8F Launcher Biopsy Guide Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 17, 2003 Received: June 18, 2003
Dear Mr. Boucher:
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 may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Fred Boucher
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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.
D. Zuker
MP
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Attachment 2 长 63067 |
D. Indications For Use
- Medtronic 7F and 8F Launcher Right Ventricular Biopsy Device Name: Guide Catheters
- The Medtronic 7F and 8F Launcher Right Ventricular Indications for Use: Biopsy Guiding Catheters are intended to be used for the percutaneous introduction of biopsy forceps into the right ventricle of the heart.
None Contraindications:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K030671 |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |