(259 days)
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.
Not Found
The provided text describes a 510(k) submission for the Jostra HL-20 Twin Pump, aiming to demonstrate its substantial equivalence to a predicate device, the Jostra HL-20 Single Head Roller Pump. The submission focuses on functional and design similarities, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device studies (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance related to the engineering and safety standards that the device adheres to, as this is the basis of the equivalence claim.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Reference to Standard) |
|---|---|
| General Safety | Complies with EN93/42: EU Council Directive 93/42/EEC concerning Medical Devices |
| Constructional Safety | Complies with IEC 601-1: IEC 601-1, 2nd Edition: 1988 (identical with DIN VDE 0750 Part 1) |
| Electromagnetic Compatibility (EMC) | Complies with EU 89/336: EMC Directive 89/336/EEC 1993 (identical with DIN VDE 0750, Part 1-2) |
| Functional Performance | "performs within its specifications and also within acceptable limits for performance standards" (Implied: this covers the specific operational aspects of the pump, which are not detailed in the provided text but are indicated to be satisfactory.) |
Study Details (as inferable from the document, recognizing this is not a diagnostic AI study):
- Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance. The "performance data" mentioned in F and G likely refers to engineering tests and measurements on the device itself to verify it meets the specified standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established here. The "ground truth" in this context is adherence to established engineering and safety standards (e.g., IEC, EU Directives).
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device or an AI system that interacts with human readers in a diagnostic context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a mechanical/electronic medical device, not an algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for the device's substantial equivalence claim is its conformity to established international safety and performance standards (e.g., EN93/42, IEC 601-1, EU 89/336).
- The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Demonstration of Equivalence):
The "study" or demonstration of equivalence for the Jostra HL-20 Twin Pump involves:
- Comparison to a Predicate Device: The new device (Twin Pump) is compared to a legally marketed predicate device (Single Head Roller Pump) regarding indications for use, technological characteristics (design, materials), and safety/effectiveness concerns.
- Adherence to Standards: Performance data (Attachment #5, not provided here) was submitted to demonstrate that the Twin Pump performs within its specifications and meets the acceptable limits of several key performance and safety standards:
- EU Council Directive 93/42/EEC (General Medical Devices)
- IEC 601-1, 2nd Edition: 1988 (Safety of Medical Electrical Equipment, Part 1: General Requirements)
- EMC Directive 89/336/EEC 1993 (Electromagnetic Compatibility)
- Conclusion: The provided data demonstrated that the HL-20 Twin Pump model is "similar in materials, design and function to that of the predicate device" and that its performance falls within acceptable limits relative to established safety and performance standards. This leads to the FDA's determination of substantial equivalence.
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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.
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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 concerningMedical Devices |
|---|---|---|
| ConstructionalSafety: | IEC 601-1: | IEC 601-1, 2nd Edition: 1988Safety of Medical Electircal Equipment,Part 1: General Requirement (Identical withDIN VDE 0750 Part 1) |
| ElectromagneticCompatibility: | EU 89/336:IEC 601-1-2: | EMC Directive 89/336/EEC1993 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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)
§ 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).