(259 days)
Not Found
No
The summary describes a mechanical pump for cardiopulmonary bypass and does not mention any AI or ML components.
No
The device aids in cardiopulmonary bypass procedures but does not inherently treat a disease or condition itself. It is part of a life-support system rather than a therapeutic intervention.
No
The "Intended Use" states it is "intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures," which describes a therapeutic or life-support function, not a diagnostic one.
No
The device is described as an "extra corporeal circulation device for perfusion" and a "Twin Pump," which strongly indicates a hardware component for moving fluids. The performance studies also reference electrical and mechanical safety standards (IEC 601-1), further supporting it as a hardware device.
Based on the provided information, the Jostra HL-20 Twin Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures." This describes a device used on a patient during a medical procedure, not a device used to test samples from a patient in a laboratory setting.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information based on laboratory tests.
- Performance Standards: The performance standards mentioned (EN93/42, IEC 601-1, EU 89/336) are general medical device standards, not specific standards for IVD devices.
Therefore, the Jostra HL-20 Twin Pump is a medical device used in a surgical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.
Product codes (comma separated list FDA assigned to the subject device)
DPW
Device Description
Not Found
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)
Yes, performance data is included in Attachment # 5.
Yes, it is evident from the data provided that the Twin Pump performs within its specifications and also within acceptable limits for performance standards such as
General: EN93/42: EU Council Directive 93/42/EEC concerning
Medical Devices
Constructional Safety: IEC 601-1: IEC 601-1, 2nd Edition: 1988
Safety of Medical Electircal Equipment,
Part 1: General Requirement (Identical with
DIN VDE 0750 Part 1)
Electromagnetic Compatibility: EU 89/336: IEC 601-1-2: EMC Directive 89/336/EEC
1993 Electromagnetic Compatibility
(Identical with DIN VDE 0750, Part 1-2)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
SUBSTANTIAL EQUIVALENCE SUMMARY
This summary follows the format of the FDA 510(k) Substantial Equivalence Decision-Making Process document.
EQUIVALENT (PREDICATE) DEVICE: K943803 Jostra HL-20 Single Head Roller Pump
MANUFACTURED BY:
Jostra, AB Lund, Sweden
A. Does the Jostra HL-20 Twin Pump have the same indications statements?
Yes, the Jostra HL-20 Twin Pump and the Jostra HL-20 Single Head Roller Pump have the same intended use which is for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less.
B. Does the Jostra HL-20 Twin Pump have the same technological characteristics, e.g., design, materials, etc.?
Yes, both products have the same technological characteristics. The materials are the same and essentially, the HL-20 Twin Pump is two half-scale predicate pumps in the same size module as the predicate device.
C. Could the new characteristics affect safety and effectiveness?
The safety and effectiveness are not affected due to the modification to the predicate device. If anything, the new product is more effective, due to its capacity of lower flow rates which are necessary during procedures such as pediatric perfusion, cardioplegia delivery, suction or venting.
The occlusion locking mechanism on the Twin Pump model does not have a stop to hold it in the open position (for adjusting occlusion) as on the predicate device. This is due to size limitations on the smaller pump head, but this change is not deemed to have an adverse effect on safety and efficacy.
1
Do the new characteristics raise new types of safety or effectiveness D. questions?
No, none of the changes to the predicate device are deemed to have an adverse effect on safety or efficacy.
E. Do acceptable scientific methods exist for assessing effects of the new characteristics?
N/A
Are performance data available to assess the effects of new characteristics? F.
Yes, performance data is included in Attachment # 5.
G. Do performance data demonstrate equivalence?
Yes, it is evident from the data provided that the Twin Pump performs within its specifications and also within acceptable limits for performance standards such as
| General: | EN93/42: | EU Council Directive 93/42/EEC concerning
Medical Devices |
|-----------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Constructional
Safety: | IEC 601-1: | IEC 601-1, 2nd Edition: 1988
Safety of Medical Electircal Equipment,
Part 1: General Requirement (Identical with
DIN VDE 0750 Part 1) |
| Electromagnetic
Compatibility: | EU 89/336:
IEC 601-1-2: | EMC Directive 89/336/EEC
1993 Electromagnetic Compatibility
(Identical with DIN VDE 0750, Part 1-2) |
CONCLUSION:
Jostra AB has provided data in this pre-market notification submission, which demonstrate that the HL-20 Twin Pump model is similar in materials, design and function to that of the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 1999
Mathy Johnson Product Manager Jostra USA 478 Media Road Oxford, PA 19363
Re: K984338 Jostra HL-20 Twin Pump II (TWO) Requlatory Class: Product Code: DPW Dated: August 4, 1999 Received: August 6, 1999
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Kathy Johnson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial emivalence 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K984338
Device Name:
Jostra HL-20 Twin Pump
Indications for Use:
The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurie L. Barker, PA
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
(Optional Format 3-10-98)