(98 days)
Not Found
No
The device description details a manually adjusted pneumatic compression system with fixed inflation/deflation cycles and pressure gradients. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "primary or adjunctive treatment of primary or secondary lymphedema," "treatment of venous insufficiency and chronic venous stasis ulcers," and "general treatment for swelling of the extremities," all of which are therapeutic applications.
No
The device is a pneumatic compression device used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is a "pneumatic compression device ('pumps') with associated compressible garment sleeves," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a sequential, pneumatic compression device used for the treatment of conditions like lymphedema, venous insufficiency, and swelling of the extremities. These are all conditions treated by applying external physical pressure, not by analyzing samples taken from the body.
- Device Description: The description details a "pump" and "garment sleeves" that apply air pressure externally to the extremities. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body.
- Providing information about a patient's health status based on sample analysis.
- Using reagents or assays.
- Measuring biomarkers or other biological indicators.
The device is a therapeutic device that applies physical pressure to the body for treatment purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
JOW
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or hospital use
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
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.
Key Metrics
Not Found
Predicate Device(s)
K043423, K142640, Preamendment SC-2004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted with simple, flowing lines, and the text is in a sans-serif font.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection. Send comments regarding this burden estimated and completed
of this information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary of Safety and Effectiveness
| Contact: | Barbara J. Whitman
Director, Regulatory Affairs and Quality Assurance | | | | | | | | | | | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| | Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie, NJ 07074 USA
Phone: 201-340-6422
Fax: 201-939-4503
Email: barbaraw@biocompression.com
Web: www.biocompression.com | | | | | | | | | | | | |
| Date Prepared: | April 8, 2015 | | | | | | | | | | | | |
| Device Name/Classification: | Sequential Circulator SC-2008-OC and Sequential Circulator SC-2004-OC
Class II
Cardiovascular and Respiratory Devices
21 CFR Part 870.5800
JOW - Compressible Limb Sleeve | | | | | | | | | | | | |
| Trade Name of
Proposed Device(s): | SC-2004-OC Sequential Circulator
SC-2008-OC Sequential Circulator | | | | | | | | | | | | |
| Predicate Devices: | 510(k) # Device Name Manufacturer K043423 SC-3008
Sequential Circulator Bio Compression
Systems, Inc. K142640 SC-3004-DL, SC-3008-DL
Sequential Circulators Digital Bio Compression
Systems, 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.
4
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.