Bio Compression Systems' Sequential Circulators are powered inflatable tube massagers which consist of a segmented pneumatic sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The sequential inflation of the garment simulates kneading and stroking of tissues with the hands, increasing circulation on the limb worn.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for a medical device (Sequential Circulators) and does not contain information about a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, which would include details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data for safety and electrical compatibility, and functional verification, rather than a clinical efficacy or diagnostic accuracy study.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in the format of diagnostic metrics (e.g., sensitivity, specificity, AUC) or a study proving those criteria are met. Instead, it lists technical standards and verification testing.

Acceptance Criteria (Standards and Tests)	Reported Device Performance and Compliance
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012	Compliant
ANSI/AAMI HA60601-1-11:2015-08	Compliant
IEC 60601-1:2005/AMD1:2012	Compliant
IEC 60601-1-2:2014	Compliant
IEC 60601-1-6:2010/AMD1:2013	Compliant
IEC 60601-1-11:2015	Compliant
Observation of operation (Predicate Device routine acceptance tests)	Verified
Pressure testing (Predicate Device routine acceptance tests)	Verified
HiPot (dielectric withstand test) testing (Predicate Device routine acceptance tests)	Verified
Cycle time verification and validation	Verified
Treatment time verification and validation	Verified
Pressure setting endpoint testing	Verified
Operation to confirm all modes, settings, and mode/setting changes function as intended	Verified
Software verification and validation (minor level of concern)	Verified

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the device itself being tested against technical standards, not a dataset of patient cases.

3. 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 accuracy is not relevant here.

4. Adjudication method for the test set: Not applicable.

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 is not an AI/diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance relates to compliance with engineering and safety standards, and functional specifications.

8. The sample size for the training set: Not applicable. This is not a machine learning/AI device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

February 16, 2022

Bio Compression Systems, Inc. Marc Somelofski Director of RA/OA 120 West Commercial Ave Moonachie, New Jersey 07074

Re: K213533

Trade/Device Name: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL. SC-4008-DL Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 17, 2022 Received: January 19, 2022

Dear Marc Somelofski:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213533

Device Name

Sequential Circulator models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Indications for Use (Describe)

Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary K213533

Date Prepared: January 24, 2022

I. SUBMITTER

Bio Compression Systems, Inc. 120 West Commercial Avenue Moonachie, NJ 07074, USA Phone: +1-201-939-0716

Contact Person: Marc L. Somelofski

II. DEVICE

Device Name	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Trade/Proprietary Name	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Common/Usual Name	Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Classification Name	Powered inflatable tube massager (21 CFR 890.5650)
Product Code	IRP
Class	Class II

III. PREDICATE DEVICE

2004-OC Massage System, 2008-OC Massage System (K122112).

Reference devices K030437, K122154, K133483, K160608, K183169, and K210967 are mentioned.

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

	Subject Device(K213533)	Predicate Device(K122112)	Comparison
Indications forUse	Intended to temporarilyrelieve minor muscleaches and/or pains, and totemporarily increasecirculation to the treatedarea in people who are ingood health.	The 2004-OC and 2008-OCMassage Systems arepowered inflatable tubemassagers intended totemporarily relieve minormuscle aches and/or pains,and to temporarily increasecirculation to the treated areas.The devices are intended forhome use by people who arein good health.	Subject Deviceindications are moreconcise. Otherdevices in thecategory with similartechnologicalcharacteristics havebeen cleared forthese indications(Reference DevicesK160608, K210967).
	Prescription/over-the-counter use	Over-The-Counter	Over-The-Counter	Identical
			Subject Device(K213533)	Predicate Device(K122112)	Comparison
		Operating Principle	Same as Predicate	An air compressorgenerates air flow in astationery disc valve.A motor turns the topdisc valve whichdirects air and trigger'sa micro switch.	Identical
	Power SupplyRating	100-240V, 50/60 Hz	120 VAC, 60 Hz	Equivalent - the SubjectDevice and Predicate Deviceboth connect to mains power.This is the same as othersimilar cleared devices(Reference Device K160608).
	Rated Input	12VDC, 3A	120 VAC, 0.5 A	Equivalent - the SubjectDevice has a lower inputvoltage. This is the same asother similar cleared devices(Reference Device K160608).
	ElectricalClassification	Class II	Class II	Identical
	Applied Part	Type BF	Type BF	Identical
	Ingress Protection	IP21	IP21	Identical
	Cycle Time	· 1000 series: 60-120seconds in 30-second increments• 2000/4000 series:60-120 seconds in15-secondincrements	• 2004-OC:90 seconds• 2008-OC:45 seconds	Equivalent
	Treatment Time	Continuous or timedas follows:· 1000 series: 30-120minutes adjustablein 30-minuteincrements• 2000/4000 series:10-120 minutes in 5-minute increments	Continuous	Equivalent
	Subject Device(K213533)	Predicate Device(K122112)	Comparison
Pressure Range	• 20-100 mmHg,adjustable in 5mmHg increments• 10-120 mmHg,adjustable in 1mmHg increments• 0-120 mmHg,adjustable in 1mmHg increments	30-80 mmHg,adjustable in 1 mmHgincrements	The Subject Device has abroader range of pressureselections. The SubjectDevice's ranges are similar toother cleared devices in thiscategory with the sametechnological characteristicsand indications (ReferenceDevices K160608, K183169,K210967).
Pressure Gradient(decrease/proximalchamber)	-1 mmHg (8-chambermodels) or -2 mmHg(4-chamber models)	-1 mmHg	Equivalent - the SubjectDevice's 8-chamber modelsare identical, and the 4-chamber models have thesame total gradient as thePredicate Device's model2008-OC
Weight	• SC-1004-DL, SC-2004-DL: 3.3 lbs.(1.5 kg)• SC-1008-DL, SC-2008-DL: 3.65 lbs.(1.66 kg)• SC-4004-DL: 3.5 lbs.(1.59 kg)• SC-4008-DL: 3.85lbs. (1.75 kg)	8 lbs. (3.63 kg)	Similar - The SubjectDevice's models are lighter
Dimensions	• 1000 series: 4.5" x11.75" x 7.75" (114mm x 298 mm x 197mm)• 2000/4000 series:4.5" x 12" x 7.34"(114 mm x 304 mmx 186 mm)	5.5" x 12" x 8"(140 mm x 305 mm x203 mm)	Similar
Inflatable Sleeves("Garments")	Uses Predicate'sgarments	200 Denier NylonOxford, coated with 3mil of Polyurethane	Identical or identical materialcovering additional anatomicareas (shoulder, back,hand/wrist, ankle, elbow,knee). This is the sameanatomic areas as othercleared devices in thiscategory with similartechnological characteristicsand indications (K030437,K122154, K133483)
	Subject Device(K213533)	Predicate Device(K122112)	Comparison
Features	• Adjustable CycleTime• Adjustable Pressure• Usage Meter• Focus TherapyMode (2000/4000series)• Pause• Pre-Therapy Mode(SC-4008-DL)• Timed Treatment• Individual ChamberAdjustment (4000series)	• Adjustable Pressure	The Subject Device hasadditional features. Thesefeatures are similar or thesame as other cleareddevices in this category withsimilar technologicalcharacteristics andindications (ReferenceDevices K160608, K183169,K210967).
Software SafetyClass (IEC 62304)	A	N/A	The Subject Device has aprinted circuit board andsimple software. This is thesame as other cleareddevices in this category withsimilar technologicalcharacteristics and the sameindications K160608,K183169, K210967).

V. INDICATIONS FOR USE

{5}------------------------------------------------

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

{6}------------------------------------------------

{7}------------------------------------------------

The Subject Device has the same technological characteristics with respect to design, materials used, and construction.

Subject Device and Predicate Device have the same operating principle and use . the same disc valve assembly for operation
. Components used in Subject and Predicate Devices are identical, the same material, or have the same specifications
The Predicate Device uses the Subject Device's compression garments. ●
Subject Device and Predicate Device have the same or similar performance specifications

The differences between the Subject Device and Predicate Device exist in similar cleared devices and do not raise any different questions of safety and/or effectiveness.

The difference in rated input and power supply rating is equivalent and the same as similar cleared devices (Reference Device K160608).
The Subject Device's broader range of pressure selections is similar to other ● cleared devices in this category with the same technological characteristics and indications (Reference Devices K160608, K183169, K210967).
The Subject Device's additional features are the same as other cleared devices in this category with similar technological characteristics and the same indications (Reference Devices K160608, K183169, K210967).
The Subject Device has a printed circuit board and simple software. This is the ● same as other cleared devices in this category with similar technological

{8}------------------------------------------------

characteristics and the same indications K160608, K183169, K210967). Additionally, the Subject Device and Predicate device have the same operating principle.

The Subject Device has additional garment models covering additional anatomic ● areas. These are the same areas as other cleared devices in this category with similar technological characteristics and the same indications (K030437, K122154, K133483).

VII. PERFORMANCE DATA

The following testing and performance data were provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC)

. ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012
ANSI/AAMI HA60601-1-11:2015-08 ●
IEC 60601-1:2005/AMD1:2012 ●
IEC 60601-1-2:2014 ●
. IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-11:2015

Predicate Device routine acceptance tests conducted on Subject Device

Observation of operation ●
Pressure testing ●
HiPot (dielectric withstand test) testing ●

Functional verification and validation testing

Cycle time verification and validation .
Treatment time verification and validation .
Pressure setting endpoint testing .
. Operation to confirm all modes, settings, and mode/setting changes function as intended

{9}------------------------------------------------

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The software for this device is considered as a "minor" level of concern and there are no cybersecurity risks.

Clinical/Animal Studies

Clinical/animal studies were not submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence.

VIII. CONCLUSION

The data included in this submission demonstrates that the Subject Device is substantially equivalent to the legally marketed Predicate Device and performs comparably to the Predicate Device that is currently marketed for the same intended use.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).