(150 days)
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.
Medtronic® 7F and 8F Launcher Biopsy Guide Catheter
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.
This document is a 510(k) summary for the Medtronic 7F and 8F Launcher Biopsy Guide Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for, say, an AI-powered diagnostic device.
Here's an analysis based on the provided text, addressing your points as much as possible given the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of medical device (guide catheter), the "acceptance criteria" are not reported as numerical performance metrics like sensitivity/specificity. Instead, they relate to meeting safety and efficacy standards and demonstrating substantial equivalence to pre-existing, legally marketed devices. The "performance" is implicitly demonstrated by meeting these standards and showing that the new device shares fundamental characteristics with its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantial equivalence in materials, components, design, packaging, and sterilization to predicate devices. | "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." |
| Indications for Use: Equivalence to predicate devices. | "The indications for use are identical to the Medtronic SHERPA II (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." |
| Biocompatibility: Meet appropriate biocompatibility standards. | "All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic Launcher Biopsy Guide Catheter." |
| Performance Standards/Specifications: Meet all applicable standards and specifications for intended use. | "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." |
| Substantial Equivalence: Deemed substantially equivalent to legally marketed predicate devices. | The device was deemed "substantially equivalent" to: - 7F Launcher Guide Catheter (K022764) - 8F Launcher Guide Catheter (K023402) - SHERPA, SHERPA II (commercialized as Vector) and ASCENT biopsy Guide Catheters (K944668) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of diagnostic device performance. The testing mentioned ("biocompatibility tests" and "testing verified that... meet all applicable standards") refers to engineering and bench testing, likely involving material samples or prototypes, not patient data in the typical sense of a diagnostic algorithm. Therefore, no specific sample size for a "test set" or data provenance (country, retrospective/prospective) is applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical "test set" with ground truth to be established in this submission, this information is not applicable and not provided.
4. Adjudication Method for the Test Set
Again, given the nature of a 510(k) for a guide catheter, adjudication methods for a test set are not applicable or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC study was done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human interpretation is involved, often with AI assistance. This submission is for a physical medical device (catheter), not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or mentioned. This device is a physical tool for medical procedures, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically used in AI/diagnostic device evaluation does not apply to this submission. The "ground truth" in this context is adherence to engineering specifications, material safety standards, and functional equivalence to predicate devices, verified through physical and chemical testing.
8. The Sample Size for the Training Set
There is no "training set" mentioned or applicable to this type of device submission. Training sets are used for machine learning algorithms, which are not relevant here.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set," this information is not applicable.
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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 GuideCatheter | |
| Common Name: | Guide Catheter | |
| Classification Name: | Intravascular Catheter / Percutaneous Catheter | |
| C. | Predicate Device Names | Medtronic® 7F and 8F Launcher Guide CathetersMedtronic SHERPA II (Vector)Guide Catheters |
| D. | Device Description: | Medtronic® 7F and 8F Launcher Biopsy GuideCatheter |
| E. | Intended Use | The Medtronic 7F and 8F Launcher Biopsy guideCatheters provide a pathway through which therapeutidevices are introduced. The guiding catheter isintended to be used to for the percutaneousintroduction 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:
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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.
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- 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:
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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.
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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
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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 | |
|---|---|
| ---------------------- | -- |
§ 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).