The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.

Device Description

The device consists of a manual pump (e.g., the user manually adjusts the pressures, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing discrete, segmented inflatable chambers externally applied over the affected extremity. The pump consists of a compressor capable of a maximum pressure of 150mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). . A calibrated dial gauge displays pressure in the range of 0-125mmHg.

As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the chambers are adjustable - pressure to chambers 1 &2 is controlled by a user-adjusted regulator on the pump. Pressure in chambers 384, 5&6, and 7&8 can be individually lowered from the default factory settings.

Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:

AI/ML Overview

The provided text is a 510(k) summary for the Model SC-3008 Sequential Circulator, a medical device. It states that "Performance testing was performed and assures that the product meets its specifications." However, it does not provide details on specific acceptance criteria, the results of the performance testing, or the methodology used for the study.

Therefore, many of the requested details about acceptance criteria, study design, and results cannot be extracted from the given text.

Here is what can be inferred from the text:

1. Table of acceptance criteria and reported device performance:

The document states "Performance testing was performed and assures that the product meets its specifications." This implies that there were specifications (acceptance criteria) that the device performance was compared against, and the device met them. However, the specific criteria and actual reported performance values are not provided in the text.

2. Sample size used for the test set and the data provenance:

Not provided. The document does not describe a clinical study with a test set of data. It only mentions "Performance testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This device is a sequential circulator, a physical therapy device. The concept of "ground truth" established by experts in the context of image interpretation or diagnostic tools typically does not apply to this type of device's performance testing described here.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set involving expert adjudication is described.

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:

Not applicable. This device is not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a manual pneumatic compression device, not an algorithm. Its performance is inherent in its mechanical operation.

7. The type of ground truth used:

Not provided. Given the nature of the device, "ground truth" for its performance would likely refer to objective measurements of pressure, cycle times, gradient accuracy, and durability against predefined engineering specifications. However, the specific type of ground truth (e.g., direct measurement, simulated conditions, etc.) and its establishment are not described.

8. The sample size for the training set:

Not applicable/Not provided. This is not a machine learning or AI device, so there is no training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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FEB - 1 2005

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201-939-0716 _ 800-888-0908 _ Fax: 201-939-4503 120 W. Commercial Avenue, Moonachie, NJ 07074

510(k) Summary Model SC-3008 Sequential Circulator 510(k) Number Ko 4342 3

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1. APPLICANT'S INFORMATION: Ron Motherwell Executive Vice President 201 939-0716 PH: 201 939-4503 FX: http://www.biocompression.com Internet: Medical Establishment 2424387 Registration No.:
1. SUBMITTER'S INFORMATION James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44141 440 546.4936 PH/FX: 724 7.13.2298 Mobile: coastalcg@earthlink.net E-mail: http://www.coastalcg.com Internet:
ന് Date:

November 27, 2004

4. DEVICE INFORMATION
DEVICE NAME:	Model SC-3008 Sequential Circulator
Classification Panel:	Cardiovascular and Respiratory Devices
Classification Number:	870.5800
Product Nomenclature:	Compressible Limb Sleeve
Product Code(s):	JOW
Trade/Proprietary Name:	Model SC-3008 Sequential Circulator
Common Name:	Model SC-3008 Sequential Circulator

5. DEVICE CLASSIFICATION: Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.

1. PREDICATE DEVICE(s):
- K810338 Lymphapress .
- (Pre-amendments) The Sequential Circulator .

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7. DEVICE DESCRIPTION:

Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:

Arm - Small	Leg - Small	Leg - Adjustable Small
Arm - Medium	Leg - Medium	Leg - Adjustable Medium
Arm - Large	Leg - Large	Leg - Adjustable Large
Arm - w/ Shoulder	Arm - Custom	Leg - Custom

8. INDICATIONS FOR USE:

The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device intended for the primary or adjunctive \ treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.

9. TECHNOLOGICAL CHARACTERISTICS:

The manufacturer believes that the technological characteristics of the Model SC-3008 Sequential Circulator are substantially similar to those of the predicate devices.

10. PERFORMANCE DATA:

Performance testing was performed and assures that the product meets its specifications.

11. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the Model SC-3008 Sequential Circulator is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio Compression Systems, Inc. c/o Ned Devine Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

K043423 Re:

Model SC-3008 Sequential Circulator Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 10, 2004 Received: December 13, 2004

Dear Mr. Devine:

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.

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Page 2 - Mr. Ned Devine

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 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. buchares DWVWA

Image /page/3/Picture/5 description: The image shows a black and white drawing of a symbol. The symbol is abstract and appears to be a stylized letter or character. It has curved lines and sharp angles, creating a unique and somewhat complex design. The symbol is the only element in the image, set against a plain white background.

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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510(k) Number (if known): K043423

Device Name: Model SC-3008 Sequential Circulator

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

DURING lectures

ESEN Sign-Off) SION of Cardiovascular Devices

"Wi Number_K04 "

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).