(92 days)
No
The description focuses on mechanical and basic electronic control of pneumatic compression, with no mention of AI/ML terms, data training, or complex algorithmic decision-making.
Yes
The device is intended for the treatment of conditions such as lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers, and for the prophylaxis of deep vein thrombosis (DVT). These are therapeutic applications.
No
The device description states it is a treatment device, not a diagnostic one. It stimulates fluid and blood flow, which is a therapeutic action.
No
The device description clearly outlines hardware components such as a pump, motor, air compressor, disc valves, and micro switch, in addition to the software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a sequential pneumatic compression device that applies external pressure to a limb. It works by physically compressing the limb to stimulate fluid movement and blood flow.
- Intended Use: The intended uses listed (lymphedema, peripheral edema, venous insufficiency, venous stasis ulcers, DVT prophylaxis) are all conditions treated or prevented through physical means, not through the analysis of biological specimens.
- Device Components: The components described (motor, air compressor, valves, micro switch, softkeys, display) are all related to generating and controlling pneumatic pressure, not to analyzing biological samples.
- Lack of Specimen Handling: There is no mention of the device interacting with or analyzing any biological specimens.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") 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 inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or healthcare setting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 continuous and timed 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
Comparative pressure testing of Subject and Predicate Device Individual Chamber Adjustment
- The standard gradient setting ●
- . Typical upper extremity settings
- Typical fibrotic leg setting .
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 ofPremarket 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K043423, K122112, K131306, K150953, K171793, K182003, K203178
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 14, 2021
Bio Compression Systems, Inc. Marc Somelofski Director of RA/QA 120 West Commercial Ave Moonachie, New Jersey 07074
Re: K210417
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 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 13, 2021 Received: April 15, 2021
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 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
1
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.
Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210417
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)
The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.
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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Image /page/3/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is blue and white. The word "BIO" is in large, bold letters, and the words "COMPRESSION SYSTEMS INC." are in smaller letters to the right of "BIO". There are vertical blue lines on either side of the text.
Section 5: Summary
Date Prepared: April 13, 2021
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 | Compressible Limb Sleeve (21 CFR 870.5800) |
| Product Code | JOW |
| Class | Class II |
III. PREDICATE DEVICE
Sequential Circulator models SC-3004-DL and SC-3008-DL (K142640).
Reference devices K043423, K122112, K131306, K150953, K171793, K182003, and K203178 are mentioned.
4
Image /page/4/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and consists of the word "BIO" in large, bold letters, followed by the words "COMPRESSION SYSTEMS INC." in smaller letters. The logo is flanked on both sides by a series of vertical bars of varying widths, also in blue. The bars give the logo a sense of depth and dimension.
IV. DEVICE DESCRIPTION
Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") 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 inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow.
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
(K210417) | Predicate Device
(K142640) | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Bio Compression
Systems' Sequential
Circulators are sequential,
pneumatic compression
devices intended for either
primary or adjunctive
treatment of lymphedema,
peripheral edema,
lipedema, venous
insufficiency, and venous
stasis ulcers. Sequential
Circulators are also
intended for the
prophylaxis of deep vein
thrombosis (DVT).
Intended for use in a home
or healthcare setting. | The Bio Compression
Systems' SC-3008-DL, SC-
3004-DL, SC-3004DC-DL, and
SC-2008-DL are sequential,
pneumatic compression
devices intended for either
primary or adjunctive
treatment of primary or
secondary lymphedema. The
devices are also intended for
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 devices are
intended for both home and
hospital use | The addition of the
lipedema and deep
vein thrombosis
prophylaxis
indications is not a
new use; devices in
the category with
similar characteristics
and indications have
been cleared for
these indications
(Reference Devices
K131306, K182003,
K203178). |
V. INDICATIONS FOR USE
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Image /page/5/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and white. The word "BIO" is in large, bold letters, with vertical bars on either side. To the right of "BIO" are the words "COMPRESSION SYSTEMS INC." in smaller letters.
| | Subject Device
(K210417) | Predicate Device
(K142640) | Comparison |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contra -
indications | Compression IS NOT
recommended in the
following conditions:
• Infections in the limb,
including cellulitis, without
appropriate antibiotic
coverage
• The presence of
lymphangiosarcoma
• Suspicion or confirmation
of the presence of Deep
Vein Thrombosis (DVT)
• Inflammatory phlebitis or
episodes of pulmonary
embolism
• Congestive Heart Failure
(CHF) unless controlled by
medication
• Other indications as
identified by the treating
physician | Compression IS NOT
recommended in the following
conditions:
• Infections in the limb,
including cellulitis, without
appropriate antibiotic coverage
• The presence of
lymphangiosarcoma
• Suspicion or confirmation of
the presence of Deep Vein
Thrombosis (DVT)
• Inflammatory phlebitis or
episodes of pulmonary
embolism
• Congestive Heart Failure
(CHF)
• Active cancer except for
palliative care
• Other indications as identified
by the treating physician | The cancer
contraindication and
clarifies the CHF
contraindication.
Removal of the
cancer
contraindication does
not suggest a new
use. Devices in the
category with similar
characteristics and
indications have been
cleared without this
contra-indication
(Reference Devices
K182003, K203178). |
| Prescription/
over-the-
counter use | Prescription | Prescription | Identical |
TECHNOLOGICAL CHARACTERISTICS WITH VI. COMPARISON OF THE PREDICATE DEVICE
| | Subject Device
(K210417) | Predicate Device
(K142640) | 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 | 120-240V, 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 K203178). |
| | Subject Device
(K210417) | Predicate Device
(K142640) | Comparison |
| 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 K203178). |
| 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 | 60 seconds | Similar - other devices in this
category with the same
operating principle have cycle
times longer than 60
|
| Treatment Time | Continuous or
adjustable as follows:
• 1000 series: 30-120
minutes adjustable
in 30-minute
increments
• 2000/4000 series:
10-120 minutes in 5-
minute increments | Continuous or 60
minutes | Equivalent |
| 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 | 0-120 mmHg,
adjustable in 1 mmHg
increments | Equivalent - Endpoint
pressure values are not
frequently used |
| Pressure Accuracy | ± 20% | ± 20% | Identical |
| 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 SC-
3008-DI |
| | Subject Device
(K210417) | Predicate Device
(K142640) | Comparison |
| Software Safety
Class (IEC 62304) | A | A | Identical |
| Weight
(4-chamber model) | • 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) | • SC-3004-DL: 5.65
lbs.
(2.56 kg)
• SC-3008-DL: 5.9 lbs.
(2.68 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) | 4.5" x 11.75" x 7.75"
(114 mm x 298 mm x
197 mm) | Similar |
| Compression
Sleeves
("Garments") | Uses Predicate's
garments | 200 Denier Nylon
Oxford, coated with 3
mil of Polyurethane | Identical |
| Features | • Adjustable Cycle
Time
• Adjustable Pressure
• Compliance/Usage
Meter
• Focus Therapy
Mode (2000/4000
series)
• Pause
• Pre-Therapy Mode
(SC-4008-DL)
• Timed Treatment
• Individual Chamber
Adjustment (4000
series) | • Adjustable Pressure
• Compliance/
Usage Meter
• Pre-Therapy Mode
(SC-3008-DL)
• Timed Treatment
• Individual Chamber
Adjustment | Minor differences in features.
Subject Device:
• has Adjustable Cycle Time
- the range of which is
comparable to the Predicate
Device (60 seconds) and
similar cleared devices
(Reference Device
K150953, 90 seconds).
• has a Focus Therapy mode
(2000/4000 series) which
doubles inflation time on a
group of garment chambers
for the first 10 minutes -
this is similar to the
Predicate Device's Pre-
Therapy mode which
inflates the most distal
group of garment chambers
for the first 10 minutes
• can pause treatment and
treatment time - this is the
same as other similar |
Section 5: Summary
Page 5-3
6
7
8
| 120 West Commercial Avenue, Moonachie, New Jersey 07074 | |||||
|---|---|---|---|---|---|
| -- | --------------------------------------------------------- | -- | -- | -- | -- |
| Subject Device
(K210417) | Predicate Device
(K142640) | Comparison |
|-----------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | cleared devices (Reference
Device K203178).
• 1000 and 2000 series lack
Individual Chamber
Adjustment feature - this is
the same as other similar
cleared devices (Reference
Device K150953). |
The Subject Device is based upon the Predicate Device and 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 Adjustable Cycle Time range is similar to cycle times for cleared devices with . the same Predicate as the Subject Device (Reference Device K150953)
- . The lack of Individual Chamber Adjustment in 1000 and 2000 series is identical as cleared devices with the same Predicate as the Subject Device (Reference Device K150953)
- The differences in rated input and power supply rating are equivalent, and the Pause feature is the same as similar cleared devices Reference Device (Reference Device K203178).
VII. PERFORMANCE DATA
The following testing and performance data were provided in support of the substantial equivalence determination.
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Image /page/9/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is in blue and consists of the word "BIO" in large block letters, with the words "COMPRESSION SYSTEMS INC." stacked to the right of the "BIO". The logo is flanked on both sides by a series of vertical blue bars.
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 continuous and timed 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
Comparative pressure testing of Subject and Predicate Device Individual Chamber Adjustment
- The standard gradient setting ●
- . Typical upper extremity settings
- Typical fibrotic leg setting .
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.
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Image /page/10/Picture/0 description: The image shows the logo for Bio Compression Systems Inc. The logo is primarily blue and white. The word "BIO" is in large, bold, blue letters, with a series of blue vertical bars on either side. To the right of "BIO" are the words "COMPRESSION SYSTEMS INC." in smaller, white letters.
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.