(103 days)
No
The device description details a mechanical system with a motor, air compressor, and valves controlled by softkeys or a touchscreen. There is no mention of AI or ML in the device description, intended use, or performance studies. The software validation is standard for medical devices and does not indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area". These are therapeutic claims.
No
The device is intended to provide temporary relief of muscle aches and increase circulation, which are therapeutic functions, not diagnostic. It does not identify or detect a disease or condition.
No
The device description explicitly details hardware components such as a motor, air compressor, disc valves, and micro switch, and the performance studies include electrical safety and functional verification of these hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health." This describes a physical therapy or massage-like function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "powered inflatable tube massager" that uses pneumatic compression to simulate massage. This is a mechanical device that interacts with the body externally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is entirely external and therapeutic in nature.
N/A
Intended Use / Indications for Use
Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.
Product codes
IRP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb worn, shoulder, back, hand/wrist, ankle, elbow, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use by people who are in good health.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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/AMD1:2013 ●
- 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
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.
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K030437, K122154, K133483, K160608, K183169, K210967
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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
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.
| | Subject Device
(K213533) | Predicate Device
(K122112) | Comparison | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | Intended to temporarily
relieve minor muscle
aches and/or pains, and to
temporarily increase
circulation to the treated
area in people who are in
good health. | The 2004-OC and 2008-OC
Massage Systems are
powered inflatable tube
massagers intended to
temporarily relieve minor
muscle aches and/or pains,
and to temporarily increase
circulation to the treated areas.
The devices are intended for
home use by people who are
in good health. | Subject Device
indications are more
concise. Other
devices in the
category with similar
technological
characteristics have
been cleared for
these indications
(Reference Devices
K160608, 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 compressor
generates air flow in a
stationery disc valve.
A motor turns the top
disc valve which
directs air and trigger's
a micro switch. | Identical |
| | Power Supply
Rating | 100-240V, 50/60 Hz | 120 VAC, 60 Hz | Equivalent - the Subject
Device and Predicate Device
both connect to mains power.
This is the same as other
similar cleared devices
(Reference Device K160608). | |
| | Rated Input | 12VDC, 3A | 120 VAC, 0.5 A | Equivalent - the Subject
Device has a lower input
voltage. This is the same as
other similar cleared devices
(Reference Device K160608). | |
| | Electrical
Classification | Class II | Class II | Identical | |
| | Applied Part | Type BF | Type BF | Identical | |
| | Ingress Protection | IP21 | IP21 | Identical | |
| | Cycle Time | · 1000 series: 60-120
seconds in 30-
second increments
• 2000/4000 series:
60-120 seconds in
15-second
increments | • 2004-OC:
90 seconds
• 2008-OC:
45 seconds | Equivalent | |
| | Treatment Time | Continuous or timed
as follows:
· 1000 series: 30-120
minutes adjustable
in 30-minute
increments
• 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 5
mmHg increments
• 10-120 mmHg,
adjustable in 1
mmHg increments
• 0-120 mmHg,
adjustable in 1
mmHg increments | 30-80 mmHg,
adjustable in 1 mmHg
increments | The Subject Device has a
broader range of pressure
selections. The Subject
Device's ranges are similar to
other cleared devices in this
category with the same
technological characteristics
and indications (Reference
Devices K160608, K183169,
K210967). | | |
| Pressure Gradient
(decrease/proximal
chamber) | -1 mmHg (8-chamber
models) or -2 mmHg
(4-chamber models) | -1 mmHg | Equivalent - the Subject
Device's 8-chamber models
are identical, and the 4-
chamber models have the
same total gradient as the
Predicate Device's model
2008-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: 3.85
lbs. (1.75 kg) | 8 lbs. (3.63 kg) | Similar - The Subject
Device's models are lighter | | |
| Dimensions | • 1000 series: 4.5" x
11.75" x 7.75" (114
mm x 298 mm x 197
mm)
• 2000/4000 series:
4.5" x 12" x 7.34"
(114 mm x 304 mm
x 186 mm) | 5.5" x 12" x 8"
(140 mm x 305 mm x
203 mm) | Similar | | |
| Inflatable Sleeves
("Garments") | Uses Predicate's
garments | 200 Denier Nylon
Oxford, coated with 3
mil of Polyurethane | Identical or identical material
covering additional anatomic
areas (shoulder, back,
hand/wrist, ankle, elbow,
knee). This is the same
anatomic areas as other
cleared devices in this
category with similar
technological characteristics
and indications (K030437,
K122154, K133483) | | |
| | Subject Device
(K213533) | Predicate Device
(K122112) | Comparison | | |
| Features | • Adjustable Cycle
Time
• Adjustable Pressure
• Usage Meter
• Focus Therapy
Mode (2000/4000
series)
• Pause
• Pre-Therapy Mode
(SC-4008-DL)
• Timed Treatment
• Individual Chamber
Adjustment (4000
series) | • Adjustable Pressure | The Subject Device has
additional features. These
features are similar or the
same as other cleared
devices in this category with
similar technological
characteristics and
indications (Reference
Devices K160608, K183169,
K210967). | | |
| Software Safety
Class (IEC 62304) | A | N/A | 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
characteristics and the same
indications 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.