(126 days)
No
The description focuses on a mechanical valve with adjustable sealing, and there is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is intended to minimize blood loss during other procedures, not to treat a condition itself.
No
The device, Medtronic model 6248VAL adjustable valve, is intended to minimize blood loss during percutaneous catheter procedures. It is a tool for blood management during a procedure, not for diagnosing a medical condition.
No
The device description clearly describes a physical, single-use valve designed to reduce blood loss during medical procedures. It mentions mechanical and performance testing, which are characteristic of hardware devices, and there is no mention of software as a component or the primary function.
Based on the provided information, the Medtronic model 6248VAL adjustable valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for minimizing blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories. This is a device used in vivo (within the body) during a medical procedure.
- Device Description: The description reinforces its function as a valve to reduce blood loss around devices inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is a surgical accessory used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.
Product codes
DTL
Device Description
The 6248VAL Adjustable Valve is a single use valve designed to reduce blood loss during percutaneous catheter procedures. The valve sealing diameter is adjustable so it may be tightened or loosened to provide an appropriate seal around devices such as leads, guidewires, and catheters, which are passed through the main valve port. Blood flow through the valve is reduced as the valve is closed.
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)
Device verification testing was performed to demonstrate the valve meets established performance criteria and to support equivalency to the referenced predicate devices. Visual, mechanical and performance testing was completed. All design and performance requirements were met. Biocompatibility testing consistent with ISO 10993-1: 2003. "Biological Evaluation of Medical devices - Part 1: Evaluation and Testing" was also conducted. The 6248VAL Adjustable Valve will be sterilized using a validated gamma radiation process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Adjustable Hemostasis Valve (model 6218VAL) K012083 and K012130, Guidant Rapido Cut-A-Way Rotating Hemostasis Valve -- K031688, Angeion Y-Adaptor with Touhy-Borst Valve K895580
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
510(K) SUMMARY
| Date Prepared: | September 06, 2005 |
|---|---|
| Date Revised: | December 28, 2005 |
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Management | |
| 7000 Central Avenue NE | |
| Minneapolis, MN 55432 | |
| Contact: | Michelle Nivala |
| Regulatory Affairs Specialist | |
| Telephone: | (763) 505-7863 |
| Fax: | (763) 505-7877 |
| E-Mail: | michelle.d.nivala@medtronic.com |
| Proprietary Name: | 6248VAL Adjustable Valve |
| Common Name: | Cardiopulmonary bypass adaptor. |
| stopcock, manifold, or fitting. | |
| Device Classification: | Class II, 21 CFR 870.4290 |
| Product Code: | DTL |
Summary of Substantial Equivalence
The intended use, design, function, materials and method of operation, of the 6248VAL Adjustable Valve are substantially equivalent with regard to these features, to the following predicate devices:
- Medtronic Adjustable Hemostasis Valve (model 6218VAL) K012083 and K012130 cleared August 28, 2001.
- · Guidant Rapido Cut-A-Way Rotating Hemostasis Valve -- K031688 cleared July 2, 2003
- · Angeion Y-Adaptor with Touhy-Borst Valve K895580 cleared April 30, 1990
Image /page/0/Picture/10 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a symbol on the left and the word "Medtronic" in bold, black letters. The symbol appears to be a stylized representation of the human body. The word "Confidential" is in a smaller, lighter font than the Medtronic name.
1
Device Description
The 6248VAL Adjustable Valve is a single use valve designed to reduce blood loss during percutaneous catheter procedures. The valve sealing diameter is adjustable so it may be tightened or loosened to provide an appropriate seal around devices such as leads, guidewires, and catheters, which are passed through the main valve port. Blood flow through the valve is reduced as the valve is closed.
Indications for Use
The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.
Technological Characteristics
Mechanical method of operation, sealing mechanism and packaging materials are substantially equivalent to the predicate devices referenced.
Summary of Testing
Device verification testing was performed to demonstrate the valve meets established performance criteria and to support equivalency to the referenced predicate devices. Visual, mechanical and performance testing was completed. All design and performance requirements were met.
Biocompatibility testing consistent with ISO 10993-1: 2003. "Biological Evaluation of Medical devices - Part 1: Evaluation and Testing" was also conducted.
The 6248VAL Adjustable Valve will be sterilized using a validated gamma radiation process.
Conclusion
Medtronic considers the 6248VAL Adjustable Valve to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
Image /page/1/Picture/14 description: The image shows the Medtronic logo with the word "Confidential" to the right of the logo. The Medtronic logo consists of a circular emblem with stylized figures inside, followed by the company name in bold, sans-serif font. The word "Confidential" is in a smaller, regular font, indicating the sensitive nature of the document or information associated with the logo.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the shape of a bird's head and wings.
JAN 1 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Ms. Michelle Nivala Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432
Re: K052459 6248VAL Adjustable Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II (Two) Product Code: DTL Dated: December 5, 2005 Received: December 6, 2005
Dear Ms. Nivala:
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 adultcration.
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 - Ms. Michelle Nivala
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 (OS) 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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Dina R. Vicines
Image /page/3/Picture/5 description: The image shows a signature. The signature is written in cursive and appears to be a stylized version of the letters 'Sa'. The signature is written in black ink and is on a white background. The signature is simple and easy to read.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K052459
Device Name: 6248VAL Adjustable Valve
Indications for Use: The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duma R. Vechner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 052459
Image /page/4/Picture/17 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left, the word "Medtronic" in bold black letters in the center, and the word "Confidential" in smaller black letters on the right. The circular graphic appears to depict a human figure.