(92 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device (Sequential Circulators) and does not describe a study that establishes acceptance criteria for a device based on expert performance or to prove a device meets acceptance criteria through a comparison with human readers or a standalone algorithm study.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, as required for 510(k) submissions to the FDA. The "acceptance criteria" discussed are primarily related to general performance, electrical safety, electromagnetic compatibility, and software verification/validation, rather than clinical performance based on ground truth established by experts.
Therefore, many of the requested points related to acceptance criteria and performance studies in the context of AI/ML or expert adjudication in a clinical setting cannot be directly extracted from this document.
However, I can provide the information that is present:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in a typical table format with quantitative performance metrics for a diagnostic or AI device (e.g., sensitivity, specificity). Instead, it lists various tests and validations performed to ensure the device performs as intended and is safe. The "reported device performance" is implied by the satisfactory completion of these tests, leading to the substantial equivalence determination.
Here's an interpretation based on the document's content:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Conclusion of Substantial Equivalence) |
|---|---|
| Compliance with Electrical Safety Standards (e.g., ANSI/AAMI ES60601-1) | Met standards, demonstrating electrical safety. |
| Compliance with Electromagnetic Compatibility (EMC) Standards (e.g., IEC 60601-1-2) | Met standards, demonstrating electromagnetic compatibility. |
| Observation of continuous and timed operation | Verified satisfactory continuous and timed operation. |
| Pressure testing | Verified accurate pressure output as per specifications (within ± 20% accuracy). |
| HiPot (dielectric withstand test) testing | Passed, indicating insulation integrity. |
| Cycle time verification and validation | Verified and validated across specified ranges (e.g., 60-120 seconds). |
| Treatment time verification and validation | Verified and validated across specified ranges (e.g., 10-120 minutes). |
| Pressure setting endpoint testing | Verified accurate pressure settings at endpoints. |
| Operation to confirm all modes, settings, and changes function as intended | Confirmed all modes, settings, and changes function as intended. |
| Comparative pressure testing for Individual Chamber Adjustment | Demonstrated similar performance to the predicate device for standard gradient, upper extremity, and fibrotic leg settings. |
| Software Verification and Validation Testing (according to FDA guidance) | Completed successfully, software considered "minor" level of concern with no cybersecurity risks. |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes in terms of a "test set" for clinical evaluation in the way an AI/ML device submission would. The testing described (electrical safety, functional verification, comparative pressure) refers to engineering and bench testing of the devices themselves, not a dataset of patient cases.
- Sample Size: Not applicable in the context of clinical "test sets" for diagnostic performance. The sample size would refer to the number of device units tested.
- Data Provenance: Not applicable. The testing is described as being conducted on the subject device and reference devices, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. The device is a pneumatic compression device, not a diagnostic imaging device or an AI/ML algorithm requiring expert ground truth for clinical performance evaluation. The "ground truth" for this device's performance is its direct physical output (e.g., pressure, cycle time) verified through engineering tests against specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication mentioned as this is not a diagnostic or AI/ML device relying on interpretation of clinical data.
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-assisted device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" used for testing would be the engineering specifications and established standards for medical devices (e.g., pressure accuracy, cycle time, electrical safety parameters). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device does not involve training of an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model.
Summary of the Study Proving Device Meets Acceptance Criteria (as described in the 510(k)):
The study to prove the device meets its "acceptance criteria" (understood here as performance specifications and safety standards) consisted of a series of bench testing, engineering verification, and validation activities. These included:
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Adherence to recognized national and international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
- Predicate Device Routine Acceptance Tests Conducted on Subject Device: This implies the new device underwent the same internal quality control and performance tests as the predicate, including continuous and timed operation observation, pressure testing, and HiPot testing.
- Functional Verification and Validation Testing: Specific tests were conducted to verify and validate cycle time, treatment time, pressure setting endpoints, and overall functionality of all modes and settings.
- Comparative Pressure Testing: Specific tests were done to compare the pressure performance of the Subject Device and Predicate Device, particularly regarding individual chamber adjustment and pressure gradients. This was crucial for demonstrating substantial equivalence for critical performance parameters.
- Software Verification and Validation Testing: Conducted in accordance with FDA guidance for medical device software, confirming its functionality and safety (classified as "minor" level of concern).
The conclusion states: "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." This statement serves as the justification that the device meets the implied "acceptance criteria" for demonstrating substantial equivalence.
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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
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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
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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.
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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 forUse | The Bio CompressionSystems' SequentialCirculators are sequential,pneumatic compressiondevices intended for eitherprimary or adjunctivetreatment of lymphedema,peripheral edema,lipedema, venousinsufficiency, and venousstasis ulcers. SequentialCirculators are alsointended for theprophylaxis of deep veinthrombosis (DVT).Intended for use in a homeor healthcare setting. | The Bio CompressionSystems' SC-3008-DL, SC-3004-DL, SC-3004DC-DL, andSC-2008-DL are sequential,pneumatic compressiondevices intended for eitherprimary or adjunctivetreatment of primary orsecondary lymphedema. Thedevices are also intended foradditional or alternatetreatment of venousinsufficiency and chronicvenous stasis ulcersassociated with venousinsufficiency as well as generaltreatment for swelling of theextremities. The devices areintended for both home andhospital use | The addition of thelipedema and deepvein thrombosisprophylaxisindications is not anew use; devices inthe category withsimilar characteristicsand indications havebeen cleared forthese indications(Reference DevicesK131306, 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 NOTrecommended in thefollowing conditions:• Infections in the limb,including cellulitis, withoutappropriate antibioticcoverage• The presence oflymphangiosarcoma• Suspicion or confirmationof the presence of DeepVein Thrombosis (DVT)• Inflammatory phlebitis orepisodes of pulmonaryembolism• Congestive Heart Failure(CHF) unless controlled bymedication• Other indications asidentified by the treatingphysician | Compression IS NOTrecommended in the followingconditions:• Infections in the limb,including cellulitis, withoutappropriate antibiotic coverage• The presence oflymphangiosarcoma• Suspicion or confirmation ofthe presence of Deep VeinThrombosis (DVT)• Inflammatory phlebitis orepisodes of pulmonaryembolism• Congestive Heart Failure(CHF)• Active cancer except forpalliative care• Other indications as identifiedby the treating physician | The cancercontraindication andclarifies the CHFcontraindication.Removal of thecancercontraindication doesnot suggest a newuse. Devices in thecategory with similarcharacteristics andindications have beencleared without thiscontra-indication(Reference DevicesK182003, 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 compressorgenerates air flow in astationery disc valve.A motor turns the topdisc valve whichdirects air and trigger'sa micro switch. | Identical |
| Power SupplyRating | 120-240V, 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 K203178). |
| Subject Device(K210417) | Predicate Device(K142640) | Comparison | |
| 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 K203178). |
| 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 | 60 seconds | Similar - other devices in thiscategory with the sameoperating principle have cycletimes longer than 60 |
| Treatment Time | Continuous oradjustable as follows:• 1000 series: 30-120minutes adjustablein 30-minuteincrements• 2000/4000 series:10-120 minutes in 5-minute increments | Continuous or 60minutes | Equivalent |
| Pressure Range | • 20-100 mmHg,adjustable in 5mmHg increments• 10-120 mmHg,adjustable in 1mmHg increments• 0-120 mmHg,adjustable in 1mmHg increments | 0-120 mmHg,adjustable in 1 mmHgincrements | Equivalent - Endpointpressure values are notfrequently used |
| Pressure Accuracy | ± 20% | ± 20% | Identical |
| 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 model SC-3008-DI |
| Subject Device(K210417) | Predicate Device(K142640) | Comparison | |
| Software SafetyClass (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: 3.85lbs. (1.75 kg) | • SC-3004-DL: 5.65lbs.(2.56 kg)• SC-3008-DL: 5.9 lbs.(2.68 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) | 4.5" x 11.75" x 7.75"(114 mm x 298 mm x197 mm) | Similar |
| CompressionSleeves("Garments") | Uses Predicate'sgarments | 200 Denier NylonOxford, coated with 3mil of Polyurethane | Identical |
| Features | • Adjustable CycleTime• Adjustable Pressure• Compliance/UsageMeter• Focus TherapyMode (2000/4000series)• Pause• Pre-Therapy Mode(SC-4008-DL)• Timed Treatment• Individual ChamberAdjustment (4000series) | • Adjustable Pressure• Compliance/Usage Meter• Pre-Therapy Mode(SC-3008-DL)• Timed Treatment• Individual ChamberAdjustment | Minor differences in features.Subject Device:• has Adjustable Cycle Time- the range of which iscomparable to the PredicateDevice (60 seconds) andsimilar cleared devices(Reference DeviceK150953, 90 seconds).• has a Focus Therapy mode(2000/4000 series) whichdoubles inflation time on agroup of garment chambersfor the first 10 minutes -this is similar to thePredicate Device's Pre-Therapy mode whichinflates the most distalgroup of garment chambersfor the first 10 minutes• can pause treatment andtreatment time - this is thesame as other similar |
Section 5: Summary
Page 5-3
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| 120 West Commercial Avenue, Moonachie, New Jersey 07074 | |||||
|---|---|---|---|---|---|
| -- | --------------------------------------------------------- | -- | -- | -- | -- |
| Subject Device(K210417) | Predicate Device(K142640) | Comparison |
|---|---|---|
| cleared devices (ReferenceDevice K203178).• 1000 and 2000 series lackIndividual ChamberAdjustment feature - this isthe same as other similarcleared devices (ReferenceDevice 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.
§ 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).