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
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartment pressures

Device Description

The IC-1545-DL Multi-Flo DVT Combo (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The applicant device is a digitally-controlled version of the predicate device, with identical specifications. There is no change in fundamental technology and no change in intended use from the predicate device, K610857. The digital modification provides identical call/thigh (KT) and foot (F) timing and pressure options as the predicate and it has the same intended use as the predicate, including prophylaxis of deep vein thrombosis (DVT) and enhancing venous and arterial circulation. Tubing connector design variations prevent interchangeability of garments between the models. The user interface consists of a soft keypad where the predicate has a rocker on/off switch and a pressure adjustment knob. The analogue pressure gauge and regulator have been removed, making the applicant unit 27% smaller and 47% lighter than the predicate, and both are designed to hang on bedrails for easy access to bed-ridden patients. The device consists of a pump, inflatable garments, and interconnection tubing. The pump compressor is capable of no more than 150 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHg, with a cycle of 15 seconds on and 45 seconds off (KT option). This is consistent with the majority of indications prescribed. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump sends air to the output ports, filling the garments with air. A digital pressure sensor maintains the pressure by turning the compression pump on and off. After 45 seconds, the timer stops the pump and opens a valve to deflate the garnents and 15 seconds later the cycle repeats. In order to achieve its intended use, the device is attached via interconnecting tubing to sleeves (garments) applied externally and bilaterally over the lower extremities. The garments contain discrete, interconnected and segmented inflatable chambers. The pump provides intermittent, rapid impulse pressurization to the chambers. The pressure can be adjusted up or down in increments of I mmHg with up and down soft key arrows, and an alarm is provided for low/no pressure. When the garnents are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. The device runs continuously until turned off. An LED display shows the pressure setting during the inflation cycle and "0" during the deflation cycle. Pressure setting can be changed by the user, while timing cycles can be changed with special instructions provided to the distributor. An alarm will alert the user if inflation pressures do not exceed 30 mmHg. All garments are supplied non-sterile and for single patient use. DVT prophylaxis garments are available in a total of three anatomical configurations as indicated to the calves or the calves and the thighs (KT) and the feet (F).

AI/ML Overview

This document describes the IC-1545-DL Multi-Flo DVT Combo Intermittent Pneumatic Compression Device, a device intended for prophylaxis of deep vein thrombosis and enhancement of venous and arterial circulation, among other uses. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Model Multi-Flo IC-1545-KT/F Intermittent Circulator).

Acceptance Criteria and Device Performance

The device's performance is accepted based on functional testing and comparison to the predicate device. The key acceptance criteria revolve around maintaining similar performance specifications and inflation cycle profiles to the predicate device, despite changes in the user interface (digital vs. analog).

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (Applicant)
Intended Use	Same as predicate: Prophylaxis of deep vein thrombosis; enhancement of venous and arterial circulation, prevention of venous stasis ulcers, etc.	Same
Principal of Operation	Intermittent Pneumatic Compression	Same
Inflation Time, each segment	15 seconds bilateral (KT), 6 seconds bilateral (F)	Same
Deflation Time	45 seconds (KT), 54 seconds (F)	Same
Recommended Inflation Pressure	45-60 mmHg (KT), 90-120 mmHg (F)	Same
Pressure Adjustment	Locking adjustable knob on regulator	Digital, soft keypad, 1mmHg increments
Pressure Gauge	0-125 mmHg, analog	0 - 120 mmHg, digital
Displayed Pressure Accuracy	± 5 mmHg of sleeve pressure, real-time pressure displayed on gauge face	± 5 mmHg of sleeve pressure, pressure set point displayed on LED. Note: The document states "Before being released every device is tested and must meet all performance specifications." which implies this accuracy is met. Specific test results beyond this general statement are not detailed.
Pause time between inflation cycles	None (deflation time is pause time)	Same
Total Cycle Time	60 seconds, 60 cycles per hour.	Same
Fail-safe hose connectors	Yes	Yes
Bilateral Treatment Option	Yes	Yes
Electrical Leakage	Not explicitly stated as a numerical criterion, but implied under "performance specifications"	Met "all performance specifications."
Pressure Adjustment	Not explicitly stated as a numerical criterion, but implied under "performance specifications"	Met "all performance specifications."
Inflation pressure in each segment	Not explicitly stated as a numerical criterion, but implied under "performance specifications"	Met "all performance specifications."
Air pressure display accuracy	± 5 mmHg of sleeve pressure (as stated above)	Met "all performance specifications."
Inflation/deflation cycle times	As stated above	Met "all performance specifications."

The overall acceptance criteria appear to be that the applicant device (IC-1545-DL Multi-Flo DVT Combo) demonstrates equivalent inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) compared to the predicate device (Model Multi-Flo IC-1545-KT/F). The device also underwent aesthetic and electrical leakage testing.

Study Information

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study with a distinct "test set" as typically understood. The closest equivalent is the functional testing performed on every device before release. The document states, "Before being released every device is tested and must meet all performance specifications." This suggests a 100% inspection/testing of manufactured units.
- Data Provenance: The functional testing is conducted internally by the manufacturer (Bio Compression Systems, Inc.). No external clinical data or country of origin for a "test set" is provided as this is not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the functional testing is the device's technical specifications and the performance of the predicate device. This is established by engineering and manufacturing standards, not medical experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies for interpretation of results by multiple experts. The functional testing described is objective and quantitative, based on predefined technical specifications.
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:
- No MRMC comparative effectiveness study was done, as this is a physical medical device (intermittent pneumatic compression device), not an imaging or AI-assisted diagnostic tool involving human reader interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence and meeting performance specifications relies on:
  - Engineering Specifications: Defined parameters for pressure, timing, etc.
  - Predicate Device Performance: The established operating characteristics and clinical efficacy of the predicate device (K610857). The applicant device is designed to operate within these "clinically-established parameters."
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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K131306

II. 510(k) Summary

APPLICANT'SINFORMATION: Jonathan Ross President Bio Compression Systems, Inc 120 West Commercial Avenue Moonachie, NJ, 07074 PH: 201 939-0716 FX: 201 939-4503 E-mail: jross@biocompression.com http://www.biocompression.com Internet: Medical Establishment Registration No .: 2424387

SUBMITTER'SINFORMATION

Maureen Garner President New World Regulatory Solutions, Inc. P.O. Box 5374 Toms River, NJ 08754 732-779-7422 PH: 732-270-4829 Fax: E-mail: NWRSinc@gmail.com Internet: www.newworldreg.com

DATE: May 23, 2013

DEVICEINFORMATION

DEVICE NAME:

IC-1545-DL Multi-Flo DVT Combo Intermittent Pneumatic Compression Device Classification Panel: Cardiological and Respiratory Devices Classification Number: 870.5800 Product Nomenclature: Compressible Limb Sleeve Product Code(s): JOW Trade/Proprietary Name: IC-1545-DL Multi-Flo DVT Combo Common Name: IC-1545-DL Multi-Flo DVT Combo Intermittent Circulator

DEVICECLASSIFICATION

Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.

PREDICATEDEVICE Model Multi-Flo IC-1545-KT/F Intermittent Circulator

JUL 2 2 2013

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DEVICEDESCRIPTION

The IC-1545-DL Multi-Flo DVT Combo (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The applicant device is a digitally-

controlled version of the predicate device, with identical specifications. There is no change in

fundamental technology and no change in intended use from the predicate device, K610857. The digital modification provides identical call/thigh (KT) and foot (F) timing and pressure options as the predicate and it has the same intended use as the predicate, including prophylaxis of deep vein thrombosis (DVT) and enhancing venous and arterial circulation. Tubing connector design variations prevent interchangeability of garments between the models.

The user interface consists of a soft keypad where the predicate has a rocker on/off switch and a pressure adjustment knob. The analogue pressure gauge and regulator have been removed, making the applicant unit 27% smaller and 47% lighter than the predicate, and both are designed to hang on bedrails for easy access to bed-ridden patients.

The device consists of a pump, inflatable garments, and interconnection tubing. The pump compressor is capable of no more than 150 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHg, with a cycle of 15 seconds on and 45 seconds off (KT option). This is consistent with the majority of indications prescribed.

All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump sends air to the output ports, filling the garments with air. A digital pressure sensor maintains the pressure by turning the compression pump on and off. After 45 seconds, the timer stops the pump and opens a valve to deflate the garnents and 15 seconds later the cycle repeats.

In order to achieve its intended use, the device is attached via interconnecting tubing to sleeves (garments) applied externally and bilaterally over the lower extremities. The garments contain discrete, interconnected and segmented inflatable chambers. The pump provides intermittent, rapid impulse pressurization to the chambers. The pressure can be adjusted up or down in increments of I mmHg with up and down soft key arrows, and an alarm is provided for low/no pressure. When the garnents are inflated, they compress the veins in the calf, expelling blood from the leg, overcoming blood stasis and promoting circulation.

The device runs continuously until turned off. An LED display shows the pressure setting during the inflation cycle and "0" during the deflation cycle. Pressure setting can be changed by the user, while timing cycles can be changed with special instructions provided to the distributor. An alarm will alert the user if inflation pressures do not exceed 30 mmHg.

All garments are supplied non-sterile and for single patient use. DVT prophylaxis garments are available in a total of three anatomical configurations as indicated to the calves or the calves and the thighs (KT) and the feet (F).

INDICATIONSFORUSE

When used with GID-3045-T Calf/Thigh or GID-3045-K Calf garments:

[ Intended for prophylaxis of deep vein thrombosis
When used with GI-3045-F Foot Garments
I Intended for prophylaxis of deep vein thrombosis
□ Enhancement of venous and arterial circulation

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O Prevention of venous stasis ulcers
7 Reduction of acute or chronic edema
[ Reduction of lower limb pain due to surgery or trauma
O Reduction of compartment pressures

TECHNOLOGICALCHARACTERISTICS

The manufacturer believes that the technological characteristics of the modified IC-1545-DL Multi-Flo Combo device are substantially similar to those of the predicate IC-1545-KT and -F Multi-Flo devices. The user interface has been modified from a regulator and analogue dial gauge in the predicate to a digital pressure sensor and LED display in the applicant device. In place of a manual dial on a regulator in the predicate device, the pressure can be increased or decreased in increments of I mmHg via a soft keypad on the applicant device.

PERFORMANCEDATA

Before being released 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 segment, air pressure display accuracy, and inflation/deflation cycle times. The results demonstrate comparable inflation cvcle profiles (rise times. inflation pressures, deflation times and cycle times) between the applicant and predicate devices.

STATEMENTOFSUBSTANTIALEQUIVALENCE

Similarities

Both the applicant and the predicate devices provide continuous intermittent pressure bilaterally to the foot, calf or calf and thighs using inflatable garments. The applicant and predicate devices have the same intended use and indications for use, both operate within the same clinicallyestablished parameters and both have the same performance specifications. The applicant and predicate devices use the same prescribed inflation pressures, inflation and deflation times and cycle times.

Differences

The applicant device utilizes a digital pressure sensor and LED pressure display while the predicate device utilizes an analogue gauge and needle display. The applicant has soft key up and down arrows to adjust pressure up or down, accessible by pressing an access sequence on the soft keys, while the predicate device has a locking pressure control knob attached to a regulator.

Both the predicate and the applicant devices operate within the same clinically-established parameters. The differences between the predicate and the applicant devices do not impact safety or effectiveness. A table illustrating the similarities and differences is provided below.

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Parameter	· Predicate K061857Models IC-1545-KT and -F	DigitalIC-156-DL-Multi FloDVT Combo
Intended Use	KT and F: Prophylaxis of deep vein thrombosis.F: enhancement of venous and arterialcirculation, prevention of venous stasis ulcers, assistin healing of cutaneous ulcers, reductionof acute or chronic edema, reduction of lowerlimb pain due to surgery or trauma, reduction ofcompartmental pressures.	Same
Principal of Operation	Intermittent Pneumatic Compression	Same
Weight	8 pounds	4.25 pounds
Dimensions, inches	5.5 H X 8 L X 12 W	6 H x 8 W x 8 D
# of Segments ingarment(s)	1 - 4	Same.
Inflation Time, eachsegment	15 seconds bilateral (KT)6 seconds bilateral (F)	Same
Deflation Time	45 seconds(KT)54 seconds (F)	Same
RecommendedInflation Pressure	45-60 mmHg (KT)90-120 mmHg (F)	Same
Pressure Adjustment	Locking adjustable knob on regulator	Digital, soft keypad,1mmHg increments
Pressure Gauge	0-125 mmHg, analog	0 - 120 mmHg, digital
Displayed PressureAccuracy	± 5 mmHg of sleeve pressure,real time pressure displayed on gauge face	± 5 mmHg of sleevepressure, pressure setpoint displayed on LED
Pause time betweeninflation cycles	None (deflation time is pause time)	Same
Total Cycle Time	60 seconds, 60 cycles per hour.	Same
Garments Available	Calf/thigh (Model KT)Foot (Model F)	Same
Fail-safe hoseconnectors	Yes	Yes
Bilateral TreatmentOption	Yes	Yes
Power Requirements	120VAC, 60Hz, 0.5A	Same

Table of Similarities and Differences with the Predicate Device

CONCLUSION

Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the IC-1545-DL-Multi Flo DVT Combo Intermittent Pneumatic Compression Device is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the 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 logo is black and white and has a simple, clean design. The eagle is facing to the right.

Public Health Service

June 11, 2014

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

Bio Compression Systems, Inc. c/o Ms. Maureen Garner 1983 Hazelwood Road Toms River, NJ 08753 US

Re: K131306

Trade/Device Name: IC 1545-DL Multi-Flow DVT Combo Intermittent Pneumatic Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 23, 2013 Received: May 24, 2013

Dear Ms. Garner:

This letter corrects our substantially equivalent letter of July 22, 2013.

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, 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

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Page 2 - Ms. Maureen Garner

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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Indications for Use Statement

510(k) Number: K131306

Device Names: IC-1545-DL Multi-Flo DVT Combo Intermittent Pneumatic Compression Device

Indications for Use:

When used with GID-3045-T Calf/Thigh or GID-3045-K Calf 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
Reduction of acute or chronic edema
. Reduction of lower limb pain due to surgery or trauma
. Reduction of compartment pressures

Prescription Use Over-The-Counter Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. FDA

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).