Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC

K150953 · Bio Compression Systems, Inc. · JOW · Jul 16, 2015 · Cardiovascular

Device Facts

• Record ID: K150953
• Device Name: Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
• Applicant: Bio Compression Systems, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Pneumatic compression pump system; consists of compressor unit and inflatable garment sleeves. User adjusts pressure via manual knob; device delivers graduated, sequential air pressure to garment chambers (distal to proximal). Pressure held constant until all chambers inflated; then simultaneous release; cycle repeats. Used in home or hospital settings; operated by patient or clinician. Provides mechanical compression to manage lymphedema, venous insufficiency, and extremity swelling. Benefits include reduction of edema and treatment of venous stasis ulcers through improved fluid circulation.

Clinical Evidence

Bench testing only. Functional testing included electrical leakage, pressure adjustment, chamber inflation pressure, and cycle times. Results demonstrate comparable inflation cycle profiles to predicate devices.

Technological Characteristics

Pneumatic compression pump; max pressure 80 mmHg. Graduated/gradient pressurization. Manual pressure adjustment knob. Unilateral or bilateral operation. No software/algorithm; mechanical/pneumatic control. Class II device.

Indications for Use

Indicated for primary or secondary lymphedema, venous insufficiency, chronic venous stasis ulcers, and general extremity swelling. Intended for home or hospital use by patients or clinicians.

Regulatory Classification

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.

Predicate Devices

• SC-3008 Sequential Circulator (K043423)
• SC-3004-DL, SC-3008-DL Sequential Circulators Digital (K142640)
• SC-2004 Sequential Circulator (Preamendment)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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
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# 510(k) Summary of Safety and Effectiveness

| Contact: | Barbara J. Whitman<br>Director, Regulatory Affairs and Quality Assurance | | | | | | | | | | | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| | Bio Compression Systems, Inc.<br>120 W. Commercial Ave.<br>Moonachie, NJ 07074 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Web: www.biocompression.com | | | | | | | | | | | | |
| Date Prepared: | April 8, 2015 | | | | | | | | | | | | |
| Device Name/Classification: | Sequential Circulator SC-2008-OC and Sequential Circulator SC-2004-OC<br>Class II<br>Cardiovascular and Respiratory Devices<br>21 CFR Part 870.5800<br>JOW - Compressible Limb Sleeve | | | | | | | | | | | | |
| Trade Name of<br>Proposed Device(s): | SC-2004-OC Sequential Circulator<br>SC-2008-OC Sequential Circulator | | | | | | | | | | | | |
| Predicate Devices: | 510(k) # Device Name Manufacturer K043423 SC-3008<br>Sequential Circulator Bio Compression<br>Systems, Inc. K142640 SC-3004-DL, SC-3008-DL<br>Sequential Circulators Digital Bio Compression<br>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.

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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.