(89 days)
Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).
The System 2600 is a three component system consisting of a control unit, inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections. The control unit is an electro/mechanical device designed to apply a specific degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The unit utilizes a software based electronic control system, electro/mechanical compressor, and solenoid operated air inflation control valves. All electrical and mechanical components are contained in a molded plastic housing.
Pressure is generated in the control unit and is transferred to the patient by air inflation of the multisegment leg sleeves. The segments are inflated sequentially to various pressure settings to create a decreasing gradient, distal to proximal, on the lower extremity.
The inflatable multi-segment leg sleeves are designed to be wrapped comfortably around the patient's leg. They consist of multiple air chambers which can be inflated independently. There are four sizes of sleeves offered for use with the system. Two sizes have all four air chambers positioned between the ankle and knee. The other two sizes position two chambers between the ankle and knee and two chambers above the knee on the thigh.
The Jobst System 2600 monitors the sleeve pressure repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are repeatedly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in the sleeve are inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The creation of the gradient sequential condition is dependent on the sequential opening of the solenoid valves and the pressure, monitored by the pressure transducer, in each segment of the sleeve. The pressure setting is fixed and is not user selected.
The provided document describes the K980456 submission for the Jobst Athrombic Pump System 2600. The acceptance criteria and the study proving the device meets them are based on demonstrating substantial equivalence to a predicate device, the Jobst Athrombic Pump System 2500, through bench testing.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Target Parameter for System 2600) | Reported Device Performance (System 2600) | Predicate Device Performance (System 2500) |
|---|---|---|
| Target pressure: Segment 1 | 50 mmHg (controlled within tolerance) | 50 mmHg (controlled within tolerance) |
| Target pressure: Segment 2 | 45 mmHg (controlled within tolerance) | 45 mmHg (controlled within tolerance) |
| Target pressure: Segment 3 | 40 mmHg (controlled within tolerance) | 40 mmHg (controlled within tolerance) |
| Target pressure: Segment 4 | 30 mmHg (controlled within tolerance) | 30 mmHg (controlled within tolerance) |
| Rise times (time to reach target pressures) | Under three seconds | Under three seconds |
| Inflation times (total time sleeve inflated in a cycle) | Less than 30 seconds | Less than 30 seconds |
| Total cycle time | Approximately 60 seconds | Approximately 60 seconds |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical sample size of "devices" or "runs." The study was a bench test comparing two systems (System 2600 and System 2500).
- Data Provenance: Retrospective, as it refers to performance data obtained during bench testing of the two systems for comparison. The country of origin is not specified, but the submission is to the U.S. FDA by a company (Beiersdorf - Jobst, Inc.) whose address is in Charlotte, NC, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established through direct measurement of physical parameters (pressures and times) during bench testing, not through expert interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. The "ground truth" was objective physical measurements, not subjective evaluations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a mechanical pump system for DVT prevention, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a sense. The bench testing evaluated the performance of the device (both System 2600 and System 2500) on its own, measuring its output (pressures and timing) against predefined parameters. There is no "human-in-the-loop" component in the operational function of this particular device being evaluated for its core mechanical properties.
7. The type of ground truth used:
- Type of Ground Truth: Objective physical measurements and fixed engineering parameters. The "ground truth" for the comparison was that both systems should produce the same inflation cycle parameters (target pressures, rise times, inflation times, total cycle time) as they use the same controlling parameters and sleeves.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its engineering design and calibration, likely based on iterative development and testing, rather than a distinct "training set" of data.
9. How the ground truth for the training set was established:
- How Ground Truth Established for Training Set: Not applicable for an AI training set. For a mechanical device like this, the "ground truth" for its design and calibration would have been established through engineering specifications, biomechanical requirements for DVT prevention (e.g., specific pressure gradients required for effective blood flow), and iterative testing during the development process to ensure the device performs according to these specifications.
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E 1698 MAY 510(k) Summary Statement
The following is a summary of the premarket 510(k) notification to the Food and Drug Administration as to Beiersdorf - Jobst, Inc.'s intention to manufacture and market a gradient sequential athrombic pump system.
| Trade Name: | Jobst Athrombic Pump System 2600 |
|---|---|
| Common/Usual Name: | Athrombic Pump® |
| Classification Name: | Class II - 74JOW Patient Maintenance Device, Sleeve,Compressible, Limb (21 CFR 870.5800) |
| Claimed Equivalent Device: | Jobst Athrombic Pump System 2500Manufactured by: Beiersdorf - Jobst, Inc. |
Device Description:
The System 2600 is a three component system consisting of a control unit, inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections. The control unit is an electro/mechanical device designed to apply a specific degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The unit utilizes a software based electronic control system, electro/mechanical compressor, and solenoid operated air inflation control valves. All electrical and mechanical components are contained in a molded plastic housing.
Pressure is generated in the control unit and is transferred to the patient by air inflation of the multisegment leg sleeves. The segments are inflated sequentially to various pressure settings to create a decreasing gradient, distal to proximal, on the lower extremity.
The inflatable multi-segment leg sleeves are designed to be wrapped comfortably around the patient's leg. They consist of multiple air chambers which can be inflated independently. There are four sizes of sleeves offered for use with the system. Two sizes have all four air chambers positioned between the ankle and knee. The other two sizes position two chambers between the ankle and knee and two chambers above the knee on the thigh.
The Jobst System 2600 monitors the sleeve pressure repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are repeatedly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in the sleeve are
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inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The creation of the gradient sequential condition is dependent on the sequential opening of the solenoid valves and the pressure, monitored by the pressure transducer, in each segment of the sleeve. The pressure setting is fixed and is not user selected.
Intended Use:
The System 2600 is intended to help prevent deep vein thrombosis and pulmonary embolism. By compressing the lower extremities of a recumbent patient in a gradient sequential repetitive squeezing and relaxing action, the system is providing a prophylactic modality classified in 21 CFR 870.5800 - Compressible Limb Sleeves.
Technological Characteristics Comparison
The following is a comparison between the Jobst System 2500 and the Jobst System 2600. Both devices supply gradient sequential compression used to help prevent deep vein thrombosis and pulmonary embolism and are equivalent in design and function. The System 2600 is the next generation of the System 2500 and is designed to perform the same inflation cycle and utilize the same inflatable multi-segment leg sleeves as the System 2500. The System 2600 is lighter and smaller than the System 2500 and is easier to service and maintain.
The design of both systems consist of the following three main components; a Control Unit (Pneumatic Compression Unit), inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections.
The control units are both electro/mechanical devices designed to apply a selected degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The units utilize software based electronic control systems, electro/mechanical compressors, and solenoid operated air inflation control valves. Power is supplied via 115 VAC line current. - All electrical and electro/mechanical components are contained in molded plastic housings.
The techniques and technology used to control pressure are the same in both control units. Both control units monitor the sleeve pressures repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segments. Each segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are constantly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in a sleeve are inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The pressure setting is fixed and is not user selected.
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Equivalency Based Performance Data:
The System 2600 and System 2500 were bench tested to determine equivalency. Both systems are programmed to execute the same inflation cycle. They use the same controlling parameters of time and target pressures. And, they also use the same sleeves during operation. Due to these similarities, inflation cycle parameters were measured and compared.
The results of the testing demonstrates that the inflation cycles executed by the System 2600 and System 2500 are equivalent. Both systems controlled the target pressures of 50 mmHg (segment 1), 45 mmHg (segment 2), 40 mmHg (Segment 3), and 30 mmHg (segment 4) within the same tolerance. The rise times (time required to reach target pressures) were under three seconds for both systems. Inflation times (total time a sleeve is inflated in a cycle) was less than 30 seconds for both systems. Total cycle time was approximately 60 seconds for both systems.
Equivalency Conclusions:
The Jobst Athrombic Pump System 2600 (calibrated gradient sequential unit with pneumatic sleeves) is substantially equivalent to the Jobst Athrombic Pump System 2500 (calibrated gradient sequential unit with pneumatic sleeves). Both devices supply gradient sequential compression to help prevent deep vein thrombosis and pulmonary embolism. The inflation cycle pressures and timing parameters are the same and they utilize the same four (4) port conduit tubing and inflatable multisegment limb sleeves.
2/2/98
Date: 2/2/98
Kenneth M. Bolam
Prepared By: Kenneth M. Bolam Director, Medical Equipment Development Beiersdorf - Jobst. Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized symbol of three human profiles facing to the right, with three parallel lines above them.
2 1698 MAY
Mr. Kenneth M. Bolam Director of Medical Equipment Development Beiersdorf - Jobst, Inc. 5825 Carnegie Boulevard Charlotte, NC 28209-4633
Re : K980456 Jobst Athrombic Pump System 2600 Requlatory Class: II (Two) Product Code: 74 JOW Dated: February 3, 1998 February 5, 1998 Received:
Dear Mr. Bolam:
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 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 reqistration, listing of devices, qood 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 - Mr. Kenneth M. Bolam
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 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.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callaha 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): ____________________________________________________________________________________________________________________________________________________
Device Name: __ Jobst Athrombic Pump System 2600
Indications For Use:
Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Bara L. Lawrence
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).