(106 days)
No
The summary describes a physical medical device (a catheter) and its function during surgery. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical properties and biocompatibility.
Yes
The device is intended for use in venting the left heart during cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
The device is primarily intended for venting the left heart during cardiopulmonary bypass surgery. While it allows for measurement of left ventricular pressure, this pressure monitoring capability is described as an accessory feature to its primary function, rather than its sole or primary purpose being to diagnose a condition. The performance studies focus on the physical properties and safety/effectiveness compared to predicate devices, not on diagnostic accuracy.
No
The device description clearly indicates it is a physical catheter with a pressure monitoring line, not a software-only device. The performance studies also describe bench testing of physical properties like kink, clamp, and burst testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "venting the left heart during cardiopulmonary bypass surgery." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a catheter designed for insertion into the left heart. It also has a pressure monitoring line, which measures a physiological parameter (pressure) within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is a surgical device used for a therapeutic and monitoring purpose during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.
Product codes
DRA
Device Description
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left 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
The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
OCT 2 4 2001
APPENDIX III
SUMMARY OF SAFETY AND EFFECTIVENESS TRUTHFUL AND ACCURATE STATEMENT DECLARATION OF CONFORMITY
Special 510(k) Notification 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential Medtronic, Inc. Medtronic Cardiac Surgical Products 7/6/01 18
1
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY
Medtronic, Inc. Medtronic Cardiac Surgical Products 620 Watson Street S.W. Grand Rapids, MI 49504
CONTACT PERSON
Melissa Harriger Associate Product Requiations Manager Medtronic Cardiac Surgical Products 620 Watson Street SW Tel: 616-643-5519 FAX: 616-643-1017
DEVICE NAME
24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line (12524)
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
Adult Vent Catheter (K834352) Aortic Root Cannula with Pressure Monitoring Line (K831591)
DESCRIPTION OF DEVICE
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.
STATEMENT OF INTENDED USE
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The Adult Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery.
| Special 510(k) Notification | 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential |
|---|---|
| Medtronic, Inc. | |
| Medtronic Cardiac Surgical Products | 7/6/01 |
| 19 |
2
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the Adult Vent Catheter. The modification to the current Adult Vent Catheter is to include a pressure monitoring line and material change
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is being compared to the following Marketed Devices:
- Adult Vent Catheter (K834352) ●
- . Infant Vent Catheter (K834039)
- Aortic Root cannula(s) with Integral Pressure Monitoring Line (K831591) .
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has the same indications statement and intended uses as the:
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has no new technological characteristics (e.g. materials and manufacturing processes). The technological characteristic of the pressure monitoring line is common to other products in commercial distribution as follows. Additionally, using Polyvinyl Chloride (PVC) is common to other catheter products in distribution, as indicated below in the Infant Vent Catheter.
- Aortic Root Cannula with Integral Pressure Monitoring Line (K831591)
- . Infant Vent Catheter (K834039)
This technological characteristic "could affect the safety and effectiveness of the device". However, this technological characteristic does not raise new types of safety or effectiveness questions. In addition, "there are acceptable scientific methods which exist for assessing effects of this technological characteristic".
"Performance data to assess the effects of this technological characteristic" has been performed. These "performance data demonstrate" that the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is substantially equivalent to other Medtronic marketed cannula.
3
The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability.
4
Image /page/4/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Ms. Melissa Harriger Associate Product Regulation Manager Medronic Cardiac Surgery 620 Watson SW Grand Rapids, MI 49504
Re: K012143
Trade Name: 24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Steerable Regulatory Class: Class II (two) Product Code: DRA Dated: September 24, 2001 Received: September 25, 2001
Dear Ms. Harriger:
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.
5
Page 2 - Ms. Melissa Harriger
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 promated 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 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number if known: K012143 -
Device Name: 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line
Indications for Use:
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for venting the left heart during cardiopulmonary bypass surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use
OR
Over-The-Counter use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012443