(88 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical components and intended use of an extracorporeal circuit.
Yes
The device provides "extracorporeal circulation and gas exchange support," which directly assists bodily functions for therapeutic purposes during surgical procedures.
No
Explanation: The device is described as an extracorporeal circuit for supporting surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "finished, sterile device for single use only" and an "extracorporeal circuit including circulatory and gas exchange support devices," indicating it is a physical hardware system, not software only.
Based on the provided information, the Jostra Mecc System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "surgical procedures requiring extracorporeal circulation and gas exchange support". This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its use as an "extracorporeal circuit including circulatory and gas exchange support devices". This further confirms its function in supporting bodily functions during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Jostra Mecc System's function is entirely different, focusing on supporting physiological processes during surgery.
N/A
Intended Use / Indications for Use
The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Product codes
KFM
Device Description
The Jostra Mecc System is a finished, sterile device for single use only and not to be resterilized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Bentley Duraflo Treated Extracorporeal Circuit
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
DEC 1 7 2002
510 (K) Summary
| Submitter: | Jostra AG
Hechinger Straße 38
72145 Hirrlingen
Germany |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Johnson
Phone: (302) 521-9469
Fax: (281) 292-7930 |
| Date Prepared: | September 16, 2002 |
| Device Trade Name: | Jostra Mecc System |
| Common/Usual Name: | Extracorporeal Circuit |
| Classification Names: | Cardiopulmonary bypass vascular catheter, cannula, or
tubing
Cardiopulmonary bypass adaptor, stopcock, manifold, or
fitting
Cardiopulmonary bypass blood reservoir
Non-roller-type cardiopulmonary bypass blood pump
Cardiopulmonary bypass pump speed control
Cardiopulmonary bypass oxygenator
Cardiopulmonary bypass arterial line blood filter |
| Predicate Device: | Bentley Duraflo Treated Extracorporeal Circuit |
Device Description:
The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.
Indications for use:
The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Statement of Technical Characteristics Comparison:
The Bentley Duraflo Extracorporeal circuit provides a user defined tubing circuit and may provide other user specified components such as pump, gas exchange device, reservoir and filter packaged together as a "custom tubing pack". The Jostra Mecc
1
System provides the same components assembled to the manufacturer's specifications.
All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit. The instructions for the Jostra Mecc System address safety issues regarding the use of a closed loop extracorporeal circuit.
Conclusion:
The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2002
Jostra AG c/o Ms. Kathleen Johnson Jostra-Bentley Corp. 2828 N. Crescent Ridge Drive The Woodlands, TX 77381
Re: K023132
Jostra Mecc System Regulation Number: 870.4360 Regulation Name: Non-roller type CPB pump Regulatory Class: Class III (three) Product Code: KFM Dated: September 16, 2002 Received: September 20, 2002
Dear Ms. Johnson:
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.
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
3
Page 2 - Ms. Kathleen Johnson
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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kallstrom
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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Page 1 of 1
510(k) Number:
Device Name: JOSTRA MECC SYSTEM
Indications for Use
Indications for ose THE - oosta - MOSC - Systems gas exchange support for 6 hours or less.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
X Prescription Use
Odetten
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K023132
003