MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR by BIO COMPRESSION SYSTEMS, INC.

The device is available in two models (-KT and -F) and is intended for use to help prevent deep vein thrombosis (DVT) by increasing venous blood flow (prophylaxis). One DVT prophylaxis model is intended for use on the calves or calves and thighs, while the second model is intended for use on the feet. Connector variations prevent interchangeability of garments between the models.

The device for consists of a pump, inflatable garments, and interconnection tubing. The pump is manual (e.g., inflate/deflate cycle times remain constant, and pressure is pre-set at the factory), and contains a compressor capable of a maximum pressure of 150mmHg. A calibrated dial gauge displays pressure in the range of 0-125mmHg. Should the attending physician require a higher or lower pressure from the preset value, an over-ride adjustment control is available. An integrated wire bail is provided to conveniently attach the device to the patient bedrails.

For DVT prophylaxis, the device is attached via interconnect tubing to sleeves or garments containing discrete, interconnected, and segmented inflatable chambers applied externally and bilaterally over the lower extremities. The pump provides intermittent, rapid impulse pressurization to the chambers. The garment design achieves sequentially inflation of interconnected chambers distal to proximal, and a "bleeding" mechanism ensures that distal chambers are inflated to a greater pressure than the proximal ones. The last chamber bleeds off pressure to the ambient atmosphere. An external manual adjustment available for pressure override, and an alarm is provided for low/no pressure. When the bilateral DVT prophylaxis garments are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation.

Garments are available in three anatomical configurations, are supplied non-sterile, and are intended for single patient use.

The device is intended for hospital and home use.

AI/ML Overview

The provided text describes the 510(k) summary for the Bio Compression Systems Inc. Model Multi-Flo IC-1545-KT/-F Intermittent Circulator. The information focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, as well as several other requested details pertinent to a new device validation study, cannot be fully extracted from this document.

However, I can provide information based on what is available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantifiable manner for a new device. Instead, it refers to a comparison to predicate devices. The "performance data" section indicates:

Acceptance Criteria (Implied)	Reported Device Performance
Similar risetimes (time required to reach pressure) to predicate devices	Demonstrated similar risetimes to predicate devices
Similar cycle times (total inflated and deflated times within a cycle) to predicate devices	Demonstrated similar cycle times to predicate devices
Similar inflation pressures to predicate devices	Demonstrated similar inflation pressures to predicate devices
Product meets its specifications (general statement)	Performance testing was performed and assures that the product meets its specifications

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Bench testing." There is no information provided regarding:

The specific sample size (e.g., number of units tested, number of cycles performed).
The country of origin for the data.
Whether the data was retrospective or prospective (bench testing is typically prospective, but details are not given).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This device is a mechanical pump for DVT prophylaxis. Its performance is assessed through physical parameters (pressure, time) via bench testing, not by expert interpretation of clinical data or images. Ground truth in this context relates to the accurate measurement of these physical parameters, not expert consensus on medical findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As stated above, this is bench testing of physical parameters. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where multiple experts interpret ambiguous cases (e.g., medical imaging).

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 device is not an AI-powered system or diagnostic tool that involves human readers interpreting cases. It is a mechanical medical device.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. This device does not have an "algorithm" in the sense of AI. It performs a mechanical function. Its standalone performance was assessed via bench testing, focusing on its physical output (inflation cycles, pressure) as compared to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance is based on instrumentation measurements of physical parameters (risetimes, cycle times, inflation pressures) as compared to the specifications of the predicate devices. It is not based on expert consensus, pathology, or clinical outcomes data for this specific performance testing.

8. The sample size for the training set

Not applicable. The document describes a traditional 510(k) submission for a mechanical device, not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is mentioned or implied for this device's submission.

Summary

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K061857
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Image /page/0/Picture/1 description: The image shows the logo for Bio Compression Systems Inc. The logo is black and white and features the word "BIO" in large, bold letters. To the right of "BIO" is the text "COMPRESSION SYSTEMS INC." stacked on top of each other. The logo also features a series of vertical bars on either side of the text.

120 W. Commercial Avenue, Moonachie, NJ 07074 = 201-939-0716 = 800-888-0908 = Fax: 201-939-4503

510(k) Summary AUG 0 1 2006 Model Multi-Flo IC-1545-KT/ -F Intermittent Circulator 510(k) Number - - - -

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1. APPLICANT'S INFORMATION: Ron Motherwell Executive Vice President PH: 201 939-0716 FX: 201 939-4503 Internet: http://www.biocompression.com Medical Establishment Registration No .: 2424387 2. SUBMITTER'S INFORMATION James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44141 PH/FX: 440 546.4936 Mobile: 724 713.2298 E-mail: coastalcg@earthlink.net Internet: http://www.coastalcg.com 3. Date: June 1, 2006 4. DEVICE INFORMATION DEVICE NAME: Model Multi-Flo IC - 1545-KT/-F Intermittent Circulator Classification Panel: Cardiovascular and Respiratory Devices Classification Number: 870.5800 Product Nomenclature: Compressible Limb Sleeve Product Code(s): JOW Trade/Proprietary Name: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator Common Name: Model Multi-Flo IC - 1545-KT/-F Intermittent Circulator 510(k) Submission Type: Traditional Request for Confidentiality under 21 CFR §807.95: NO
1. DEVICE CLASSIFICATION: Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.

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K061857
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1. PREDICATE DEVICE(s):
- K932900 Aircast Inc. Venaflow System ●
- K965153 Huntleigh Healthcare FP5000
- . K881632 Huntleigh Healthcare Flowtron DVT AC500
- K043423 Model SC-3008 Sequential Circulator .

7. DEVICE DESCRIPTION:

Garments are available in three anatomical configurations, are supplied non-sterile, and are intended for single patient use.

The device is intended for hospital and home use.

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K061857
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1. INDICATIONS FOR USE:
- When used with GI-3045-T Knee/Thigh or GI-3045-K Knee garments:
  - · Intended for prophylaxis of deep vein thrombosis

When used with GI-3045-F Foot garments:

· Intended for prophylaxis of deep vein thrombosis
· Enhancement of venous and arterial circulation
· Prevention of venous stasis ulcers
Assist in healing of cutaneous ulcers
· Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
· Reduction of compartmental pressures
1. TECHNOLOGICAL CHARACTERISTICS:

The monufacturer believes that the technological characteristics of the Model Multi-Flo IC-1545-KT/-F Intermittent Circulator are substantially similar to those of the predicate devices.

1. PERFORMANCE DATA:
  Performance testing was performed and assures that the product meets its specifications.

Bench testing was performed, comparing the inflation cycle profiles of the product to the predicate devices. The results of the testing demonstrate similar risetimes (time required to reach pressure), cycle times (total inflated and deflated times within a cycle), and inflation pressures.

1. STATEMENT OF SUBSTANTIAL EQUIVALENCE:
  Based upon safety and performance testing, compliance with voluntary standards. and comparison to the predicate devices in terms of features, functionality, and bench comparisonal testing, the manufacturer believes that the Multi-Flo IC-1545-KT/-F Intermittent Circulator is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2014

Bio Compression Systems, Inc. c/o Mr. Ned Devine Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K061857

Trade/Device Name: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Dated: June 20, 2006 Received: June 21, 2006

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of August 1, 2006.

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

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Page 2 - Mr. Ned Devine

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 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/ReportaProblem/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,

Fernando Aguel -S

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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510(k) Number (if known):

K061857

Device Name: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator

Indications for Use:

When used with GI-3045-T Knee/Thigh or GI-3045-K Knee garments:

Intended for prophylaxis of deep vein thrombosis
When used with GI-3045-F Foot garments:
Intended for prophylaxis of deep vein thrombosis
Enhancement of venous and arterial circulation ●
Prevention of venous stasis ulcers ●
Assist in healing of cutaneous ulcers
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartmental pressures

The device is intended for hospital and home use.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 مليو 2 يومي لاعلان يلني العملات (Division Sign-Off) Division Sign-Oir)
Division ت Cardiovascular Devices

510(k) Number_ic جيك بيك كي ماينيك ك

14/263

Regulation Number and Section

§ 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).