(98 days)
The Bio Compression Systems Sequential Circulator SC-2008-OC/Sequential Circulator SC-2004-OC with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The devices are intended for home or hospital use.
The Bio Compression Systems, Inc. SC-2004-OC Sequential Circulator and SC-2008-OC Sequential Circulator, are pneumatic compression devices ('pumps') with associated compressible garment sleeves. The pumps are manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes. The pumps can operate unilaterally and bilaterally as needed.
This document is a 510(k) premarket notification for the Sequential Circulator SC-2008-OC and SC-2004-OC. The purpose of this notification is to demonstrate that the new devices are substantially equivalent to previously legally marketed predicate devices.
Here's an analysis of the provided text in relation to the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabulated format with specific pass/fail thresholds. Instead, it describes general performance specifications and testing that is conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet all performance specifications. | "Before being released to market, every device is tested and must meet all performance specifications." |
| Satisfy aesthetic acceptance criteria. | Functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times. (Implicitly met if devices are released to market.) |
| Comparable inflation cycle profiles to predicate devices. | "The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices." |
| No new potential safety risks compared to predicate devices. | "The modified devices do not introduce any new potential safety risks and are substantially equivalent to the predicate devices." (Based on risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices.) |
| Electrical leakage within acceptable limits. | Functional testing includes "electrical leakage." (Implicitly met.) |
| Accurate pressure adjustment. | Functional testing includes "pressure adjustment." (Implicitly met.) |
| Accurate inflation pressure in each chamber. | Functional testing includes "inflation pressure in each chamber." (Implicitly met.) |
| Accurate air pressure display (despite its removal in new model). | Functional testing includes "air pressure display accuracy." (This refers to testing of the predicate or ensures that the new device's knob setting corresponds accurately to the pressure, effectively replacing the visual display with a reliable mechanical setting). The text notes the display was removed for "ease of use," implying its function is now integrated or superseded by the knob's reliability. |
| Correct inflation/deflation cycle times. | Functional testing includes "inflation/deflation cycle times." (Implicitly met.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the performance testing. It states: "Before being released to market, every device is tested and must meet all performance specifications." This suggests that 100% of manufactured units undergo testing, which could be considered the "test set" in this context for manufacturing quality control, rather than a specific clinical or validation test set.
The provenance of the data is implied to be from the manufacturer's internal testing processes ("Bio Compression Systems, Inc."). No information is given regarding the country of origin of the data beyond the company's location in Moonachie, NJ, USA. The study appears to be an internal engineering validation and manufacturing quality control study, not a clinical trial; thus, it is a retrospective analysis of product performance against specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned as being involved in establishing the "ground truth" for the performance specifications or test results. The performance data seems to be based on engineering measurements and comparisons to the established specifications of the predicate devices. The "ground truth" for basic device function (like pressure, cycle times) is typically based on validated measurement equipment and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
No adjudication method is described. This type of engineering validation study generally relies on objective measurements against pre-defined engineering specifications, rather than subjective interpretation requiring adjudication among multiple parties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No MRMC study was conducted or is mentioned. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI component, and the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical medical device (pneumatic compressor) and does not involve an algorithm with standalone performance in the context of AI/software. Its performance is its direct mechanical and electrical function.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and direct measurements. For example, pressure measurements, electrical leakage tests, and timing of inflation/deflation cycles against pre-defined, acceptable ranges. It's a technical ground truth rather than a clinical one like pathology, expert consensus on images, or outcomes data. The comparability to predicate devices also serves as a ground truth for "substantial equivalence."
8. The Sample Size for the Training Set
This question is not applicable. There is no AI or machine learning component, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Bio Compression Systems, Inc. Barbara J. Whitman Director, Regulatory Affairs and Quality Assurance 120 W Commercial Ave Moonachie, NJ 07074
Re: K150953
Trade/Device Name: Sequential Circulator SC-2008-OC and Sequential Circulator SC-2004-OC
Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 23, 2015 Received: June 24, 2015
Dear Barbara Whitman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Barbara Whitman
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MA. Wilhelm
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Sequential Circulator SC-2008-OC and Sequential Circulator SC-2004-OC
Indications for Use (Describe)
The Bio Compression Systems Sequential Circulator SC-2008-OC/Sequential Circulator SC-2004-OC with associated garments are squential, pneumatic compression devices intended SC2004-0 with associated secondary lymphedema. The devices are also intended for the primary of alternate of primary of viting of venous insufficiency extramities. The devices associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The devices are intended for home or hospital use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
| Contact: | Barbara J. WhitmanDirector, Regulatory Affairs and Quality Assurance | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bio Compression Systems, Inc.120 W. Commercial Ave.Moonachie, NJ 07074 USAPhone: 201-340-6422Fax: 201-939-4503Email: barbaraw@biocompression.comWeb: www.biocompression.com | |||||||||||||
| Date Prepared: | April 8, 2015 | ||||||||||||
| Device Name/Classification: | Sequential Circulator SC-2008-OC and Sequential Circulator SC-2004-OCClass IICardiovascular and Respiratory Devices21 CFR Part 870.5800JOW - Compressible Limb Sleeve | ||||||||||||
| Trade Name ofProposed Device(s): | SC-2004-OC Sequential CirculatorSC-2008-OC Sequential Circulator | ||||||||||||
| Predicate Devices: | 510(k) # Device Name Manufacturer K043423 SC-3008Sequential Circulator Bio CompressionSystems, Inc. K142640 SC-3004-DL, SC-3008-DLSequential Circulators Digital Bio CompressionSystems, Inc. Preamendment SC-2004 Bio Compression |
Manufacturer and Bio Compression Systems, Inc. Distributor: 120 W. Commercial Ave., Moonachie, NJ 07074 USA
Proposed Device Description
The Bio Compression Systems, Inc. SC-2004-OC Sequential Circulator and SC-2008-OC Sequential Circulator, are pneumatic compression devices ('pumps') with associated compressible garment sleeves. The pumps are manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones.
Sequential Circulator
Systems, Inc.
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As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure.
Associated garments are available in a variety of standard sizes. The pumps can operate unilaterally and bilaterally as needed.
Indications For Use
The Bio Compression Systems Sequential Circulator SC-2008-0C/Sequential Circulator SC-2004-0C with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The devices are intended for home or hospital use.
Description of Device Modifications/Technological Characteristics:
The Sequential Circulators SC-2004-OC and SC-2008-OC are technologically similar to the predicate devices, SC-3008 Sequential Circulator (K043423) and SC-2004 Sequential Circulator (Preamendment Device). The modification was the removal of the pressurization display gauge from the front of the device. The Pressure Knob, used to set the desired pressurization, remains substantially equivalent to that of the predicate device. The removal of the display was ease of use for the end user. Once the desired pressure is indicated by setting the Pressure Knob, the end user does not need to read any displays, as the pressurization is consistent with the desired setting.
The modification to the subject devices has not altered the fundamental technology of the predicate devices.
Performance Data
Before being released to market, every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times. The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices.
Statement of Substantial Equivalence:
Based upon risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices, the Sequential Circulators SC-2004-OC and SC-2008-OC, are substantially equivalent to the predicate devices SC-3008 Sequential Circulator and the SC-2004 Sequential Circulator. The modified devices do not introduce any new potential safety risks and are substantially equivalent to the predicate devices.
§ 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).