The Bio Compression Systems Sequential Circulator SC-2004FC-OC with associated garments is a 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 for swelling of the extremities. The device is intended for home or hospital use.

Device Description

The Bio Compression Systems, Inc. SC-2004FC-OC Sequential Circulator is a pneumatic compression device ('pump') with associated compressible garment sleeves. The pump is manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes.

AI/ML Overview

The provided document is a 510(k) summary for the Bio Compression Systems Sequential Circulator SC-2004FC-OC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with defined acceptance criteria for a new, innovative device. Therefore, the information requested in the prompt, which is typical for studies validating AI/ML algorithms or novel medical devices, is largely not applicable or not present in this document.

However, I can extract what is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of a 510(k) for a pneumatic compression device with a minor modification.

Summary of Acceptance Criteria and Device Performance (within the context of this 510(k) submission):

The "acceptance criteria" in this context are primarily related to the functional specifications and safety of the device, ensuring the modified device performs comparably to the predicate and does not introduce new risks. The "study" for this type of device modification is typically internal engineering and performance testing.

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Functional Equivalence	Maintain core function of sequential pneumatic compression.	The device is a pneumatic compression device ('pump') that inflates and deflates segmented chambers, applied distally to proximally, with graduated pressure. The fundamental technology has not been altered.
Pressure Output	Capable of producing a maximum pressure of 80 mmHg. Provide graduated or gradient pressurization.	The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg. They provide graduated or gradient pressurization to the chambers. There are "no maximum pressure changes, as they identically match those of the predicate devices."
Inflation/Deflation Cycle	Maintain sequential inflation (distal to proximal), constant pressure hold, simultaneous release.	Identical to predicate: Sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. Pressure is held constant until all chambers are inflated, then simultaneously released. "Comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices."
User Adjustment	User can adjust pressure.	The user can adjust the Pressure Knob on the front of the device for desired pressure.
Safety - Electrical	Electrical leakage within acceptable limits.	Tested for electrical leakage. (Specific results not detailed in the summary, but implied to meet standards).
Safety - Risks Introduced by Modification	The modification (motor change) should not introduce additional safety risks.	"There is no additional risk introduced by this change." "The modified device does not introduce any new potential safety risks and is substantially equivalent to the predicate devices."
Performance - General	Meet all performance specifications (e.g., pressure adjustment accuracy, air pressure display accuracy).	"Before being released to market, every device is tested and must meet all performance specifications." "Functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times." (Specific quantitative results not detailed in the summary, but implied to meet standards).
Aesthetic Acceptance	Meet aesthetic acceptance criteria.	"In addition to aesthetic acceptance criteria..." (No details provided on what these are, but implied to be met).
Substantial Equivalence	Overall device remains substantially equivalent to predicate devices.	"Based upon risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices, the Sequential Circulator SC-2004FC-OC is substantially equivalent to the predicate devices Sequential Circulators SC-2004-OC and SC-2008-OC."

Detailed Information as Requested (with caveats for this type of submission):

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" here are defined by the required functional specifications and safety benchmarks for a pneumatic compression device, particularly in demonstrating equivalence to a predicate. The "reported device performance" indicates that the device met these criteria through internal testing.
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For this type of engineering and performance testing, it would typically be a fixed number of manufactured units from a production run, often a small sample or even just the modified prototype, to verify specifications.
- Data Provenance: This would be internal engineering test data generated by Bio Compression Systems, Inc. The document does not specify country of origin or whether it's retrospective/prospective. As it's testing of a newly modified device, it would be prospective for the modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an engineering modification to a physical device, not an AI/ML algorithm or diagnostic imaging device where expert consensus for ground truth is typically required. The "ground truth" for pressure, cycle times, and electrical safety is established by engineering standards, calibrated measurement equipment, and regulatory requirements (e.g., maximum pressure limits, electrical safety standards).
Adjudication method for the test set:
- Not Applicable. See point 3. Testing of physical device specifications doesn't involve adjudication in the way clinical studies or expert review for AI algorithms do. Results are typically pass/fail against predetermined engineering specifications.
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 is a pneumatic compression device, not a diagnostic imaging system or an AI-enabled device requiring human interpretation. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance testing is established by engineering specifications, calibrated measurement standards, and compliance with recognized voluntary standards (e.g., for electrical safety, pressure accuracy).
The sample size for the training set:
- Not Applicable. This is a physical device modification, not an AI/ML system requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. See point 8.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2017

Bio Compression Systems, Inc. Barbara Whitman Director, Regulatory Affairs & Quality Assurance 120 W Commercial Ave Moonachie, New Jersey 07074

Re: K171793

Trade/Device Name: Sequential Circulator SC-2004FC-OC Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: July 18, 2017 Received: July 19, 2017

Dear Barbara Whitman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Nicole G. Ibrahim -S

for 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K171793
Device Name	Sequential Circulator SC-2004FC-OC

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)	Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for Bio Compression Systems, Inc. Below the logo is the text "Special 510(k) Device Modification". The last line of text says "Sequential Circulators SC-2004FC-OC".

510(k) Summary of Substantial Equivalence

Contact:	Barbara J. WhitmanDirector, Regulatory Affairs and Quality Assurance
	Bio Compression Systems, Inc.120 W. Commercial Ave.Moonachie, NJ 07074 USAPhone: 201-340-6422Fax: 201-939-4503Email: barbaraw@biocompression.comWeb: www.biocompression.com
Date Prepared:	August 15, 2017
Device Name/Classification:	Sequential Circulators, SC-2004FC-OCClass IICardiovascular and Respiratory Devices21 CFR Part 870.5800JOW – Compressible Limb Sleeve
Trade Name ofProposed Device(s):	SC-2004FC-OC Sequential Circulator
Predicate Devices:	510(k) #	Device Name	Manufacturer
	K150953	SC-2004-OC and SC-2008-OCSequential Circulators	Bio CompressionSystems, Inc.

Manufacturer andDistributor:	Bio Compression Systems, Inc.120 W. Commercial Ave., Moonachie, NJ 07074 USA
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Proposed Device Description

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As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes.

Indications For Use

The Indications For Use of the modified subject device are identical to those of the predicate devices. Below are the Indications For Use for the subject device, as well as, their intended use.

Description of Device Modifications/Technological Characteristics:

The Sequential Circulator SC-2004FC-OC is technologically identical to the predicate devices, SC-2004-OC and SC-2008-OC, Sequential Circulators (K150953). The modification to the predicate device involved replacing the motor in the SC-2004-OC with the exact motor used in the SC-2008-OC, hence deriving the subject device, SC-2004FC-OC. This change enables the subject device to operate in a faster cycle time, which some patients prefer. There are no maximum pressure changes, as they identically match those of the predicate devices. There is no additional risk introduced by this change.

The model number on the front of the pump will change to identify the subject device as SC-2004FC-OC.

The modification to the subject devices has not altered the fundamental technology of the predicate devices. There have been no prior submissions for the subject device.

Performance Data

Before being released to market, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times. The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices.

Statement of Substantial Equivalence:

Based upon risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices, the Sequential Circulator SC-2004FC-OC is substantially equivalent to the predicate devices Sequential Circulators SC-2004-OC and SC-2008-OC. The modified device does not introduce any new potential safety risks and is substantially equivalent to the predicate devices.

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).