JOBST ATHROMBIC PUMP/SLEEVE by JOBST A BEIERSDORF CO.

This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800. The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.

AI/ML Overview

The provided text is related to a 510(k) submission for a sterile version of a limb sleeve used with the Jobst Athrombic Pump System 2500. This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, a 510(k) submission, especially for this type of device, does not typically involve a "study that proves the device meets acceptance criteria" in the way one might expect for a novel diagnostic AI algorithm. The goal of a 510(k) for a device like this is to show it is substantially equivalent to a predicate device, not necessarily to independently prove its efficacy through a clinical trial with specific performance metrics and corresponding acceptance criteria.

The 510(k) summary provided states:

"The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use."
"Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs."
"The Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred."

Given this context, the request for "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format typically applied to AI performance metrics (like sensitivity, specificity, accuracy) is not directly applicable to this document. The "proof" here is the argument for substantial equivalence, primarily based on the predicate device's established safety and effectiveness, and the material/operational similarity of the new sterile sleeve.

Therefore, many of the requested fields about AI-specific study details (sample size for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth types) cannot be filled from this document because it describes a different type of regulatory submission and device evaluation.

However, I can extract information related to the device and its intended use, framed within the context of substantial equivalence.

Acceptance Criteria and Device Performance (as inferred from the 510(k) process for this device type):

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (as stated or implied in the 510(k))
1. Indications for Use Equivalence: Device must have the same indications for use as a predicate device.	"Used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities." (Identical to predicate)
2. Technological Characteristics Equivalence: Device must have similar design, materials, and mode of operation as a predicate device.	- "Mode of operation" is substantially equivalent to Kendall Healthcare Product's sterile sleeve/SCD compression system. - Both sleeves are made of PVC. - Sterilized with ethylene oxide.
3. Safety and Effectiveness Equivalence: Device must be as safe and effective as the predicate device.	- The non-sterile version has "proven to be safe and effective" since 1994. - The sterile version is technologically equivalent, implying similar safety and effectiveness.
4. Performance (Mechanism of Action) Equivalence: Device achieves its therapeutic effect in a similar manner to the predicate.	"Accomplished by intermittent compression of the muscles in the lower limbs." (Identical to predicate)
5. Sterility: The sterile version must achieve and maintain sterility.	"Sterilized with ethylene oxide." (Implicitly meets sterility requirements for a sterile product, though specific validation data is not in the summary).

Study Details (Not applicable in the context of an AI study, but addressing what is relevant to the K970922 submission):

This 510(k) submission for a sterile limb sleeve is for a Class II medical device (a physical device, not an AI algorithm). The "study" isn't a traditional clinical trial with a test set and ground truth in the AI sense, but rather a demonstration of substantial equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is not an AI algorithm and such a "test set" as typically defined for AI performance evaluation was not used. The submission relies on establishing substantial equivalence to a predicate device. The predicate device's long-standing market presence (since 1994 for the non-sterile version) serves as a form of "proven safety and effectiveness."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth in the context of expert consensus for AI performance is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Kendall Healthcare Product's sterile sleeve/SCD compression system) and the existing non-sterile version of the Jobst Athrombic Pump System 2500.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for this type of device and submission.
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:
- N/A. This is a physical medical device, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device and the existing non-sterile version of the device based on its market history and regulatory clearance. This effectively functions as "outcomes data" over time, demonstrating its intended therapeutic effect and safety profile.
The sample size for the training set:
- N/A. This is not an AI algorithm.
How the ground truth for the training set was established:
- N/A. This is not an AI algorithm.

Summary

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17410422

JAN 1 3 1998

510(k) Summary of Safety and Effectiveness

The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.

The Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred.

Date: March 11, 1997

Prepared by: Angelo R. Pereira Beiersdorf-Jobst. Inc. 5825 Carnegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178

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JAN | 3 |998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Angelo R. Pereira Manager, Regulatory Affairs Beiersdorf-Jobst, Inc. 5825 Carnegie Boulevard Charlotte, NC 28209-4633

K970922 Re: Jobst Athrombic Pump/Sleeve Regulatory Class: II (Two) Product Code: 74 JOW Dated: March 28, 1997 March 31, 1997 Received:

Dear Mr. Pereira:

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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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. Angelo R. Pereira

This letter will allow you to begin marketing your device as rnio leceer will as a go a emarket 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. Calleh Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 2 Or 2

510 (k) Number (if known): _K970922

Device Name: Sterile Sleeve for Jobst Athrombic Pump

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
(Per 21 CFR 801.109) ✓

OR Over-The-Counter Use __

Optional Format 1-2-96)

DA Singh

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 4970922 510(k) Number_

Regulation Number and Section

§ 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).