(71 days)
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: • amputations (minor) • angioplasty/stent failure • arteriopathic wounds . graft failure . intermittent claudication . ischemia . night pain . rest pain . small vessel disease ● ulcers.
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (IC-BAP-DL, applicant device) is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf. The device consists of an AC-powered pump, inflatable garments, and interconnection tubing. In operation, the device is attached via the interconnection tubing to sleeves or garments containing discrete inflatable chambers, which are applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations or use with garments or sleeves from other manufacturers. The pump design provides intermittent, rapid impulse pressurization to the chambers. Inflation and deflation cvcles are requlated by a two-section valve, turned by the valve motor at three rpm. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off using information from the pressure sensor. When the garments are inflated. they compress the blood vessels in the foot and calf, expelling blood from the leg, overcoming blood stasis and promoting circulation. Pressure is pre-set at the factory to 120 mmHg, and the compressor is capable of no more pressure than 150 mmHq, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP/DOWN soft key arrows. An LED panel displays the set pressure and display "0" during the deflation cycle. Foot/calf garments are connected and are available in a range of sizes. The garments contain discrete, interconnected and segmented inflatable chambers, providing a single inflation chamber for the foot and two inflation chambers for the calf. Garments are supplied nonsterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. The device is intended for home use. and instructions are provided for the patient to attach the garments and perform therapy after physician prescription and patient orientation and education. The user interface consists of a soft keypad and UP/DOWN pressure adjustment soft kev arrows. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the 2-section valve, which turns and sends air to the two bilateral output ports, filling first the foot and then the calf garments. As the valve continues to rotate the air is released from all chambers at once and the garments deflate. The cvcle repeats three times per minute and default treatment time is one hour, controlled by an internal timer on the PCB.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance data that the device is tested against before release. However, it does not explicitly state quantitative acceptance criteria for each parameter other than the displayed pressure accuracy. Instead, it emphasizes comparable inflation cycle profiles to the predicate device.
| Parameter | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Leakage | Must meet performance specifications | Tested and meets all performance specifications |
| Pressure Adjustment | Must meet performance specifications | Tested and meets all performance specifications |
| Inflation Pressure in each segment | Must meet performance specifications | Tested and meets all performance specifications |
| Air Pressure Display Accuracy | $\pm 10$ mmHg of sleeve pressure, pressure set point displayed on LED | Tested and meets all performance specifications |
| Inflation/Deflation Cycle Times | Must meet performance specifications | Tested and meets all performance specifications; demonstrable comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times) to predicate device. |
2. Sample Size for Test Set and Data Provenance:
The document explicitly states: "Before being released every device is tested and must meet all performance specifications." This implies that the sample size for the test set is n=1 (each individual device manufactured).
The data provenance is prospective manufacturing quality control testing. The country of origin for the data is not specified, but given the US regulatory context, it would likely be where the devices are manufactured or tested.
3. Number of Experts used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable in this context. The "ground truth" here is based on the device's technical specifications and engineering measurements, not clinical expert consensus. The testing described is functional testing against engineering requirements.
4. Adjudication Method for the Test Set:
This information is not applicable. The functional testing described is a direct measurement against defined specifications, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The study focuses purely on the device's functional equivalence to its predicate, not its clinical effectiveness against human readers or other treatments.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone performance evaluation was conducted. The "Performance Data" section describes "functional testing" performed on "every device" before release, which includes objective measurements like electrical leakage, pressure adjustment, inflation pressure, air pressure display accuracy, and inflation/deflation cycle times. This is a standalone evaluation of the device's physical and functional characteristics.
7. Type of Ground Truth Used:
The ground truth used for the device's performance evaluation is based on engineering specifications and pre-defined performance parameters for the device itself and its predicate. This includes measurements against expected pressure levels, timing, and electrical safety standards.
8. Sample Size for the Training Set:
This information is not applicable. The device described is a mechanical/electronic medical device with a pre-defined and tested operational logic, not a machine learning or AI-based system that requires a "training set" in the conventional sense. Its "training" is in its design and manufacturing process.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated above.
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K131327, Page 1 of 4
II. 510(k) Summary
APPLICANT'S INFORMATION: 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 Internet: http://www.biocompression.com Medical Establishment Registration No .: 2424387
SUBMITTER'S INFORMATION
Maureen Garner President New World Regulatory Solutions, Inc. P.O. Box 5374 Toms River, NJ 08754 PH. 732-779-7422 . Fax: 732-270-4829 E-mail: NWRSinc@gmail.com Internet: www.newworldreg.com
DATE: May 6, 2013
DEVICE INFORMATION
| DEVICE NAME: | IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System |
|---|---|
| Classification Panel: | Cardiovascular and Respiratory Devices |
| Classification Number: | 870.5800 |
| Product Nomenclature: | Compressible Limb Sleeve |
| Product Code(s): | JOW |
| Trade/Proprietary Name: | IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System |
| Common Name: | BAP-DL BioArterial Plus Arterial Blood Flow Intermittent Circulator |
DEVICE CLASSIFICATION
Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular and Respiratory Devices.
PREDICATE DEVICE
Model IC-BAP BioArterial Plus Arterial Blood Flow Enhancement System
JUL 1 8 2013
14
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DEVICE DESCRIPTION
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (IC-BAP-DL, applicant device) is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device consists of an AC-powered pump, inflatable garments, and interconnection tubing. In operation, the device is attached via the interconnection tubing to sleeves or garments containing discrete inflatable chambers, which are applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations or use with garments or sleeves from other manufacturers.
The pump design provides intermittent, rapid impulse pressurization to the chambers. Inflation and deflation cvcles are requlated by a two-section valve, turned by the valve motor at three rpm. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off using information from the pressure sensor. When the garments are inflated. they compress the blood vessels in the foot and calf, expelling blood from the leg, overcoming blood stasis and promoting circulation.
Pressure is pre-set at the factory to 120 mmHg, and the compressor is capable of no more pressure than 150 mmHq, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP/DOWN soft key arrows. An LED panel displays the set pressure and display "0" during the deflation cycle.
Foot/calf garments are connected and are available in a range of sizes. The garments contain discrete, interconnected and segmented inflatable chambers, providing a single inflation chamber for the foot and two inflation chambers for the calf. Garments are supplied nonsterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. The device is intended for home use. and instructions are provided for the patient to attach the garments and perform therapy after physician prescription and patient orientation and education.
The user interface consists of a soft keypad and UP/DOWN pressure adjustment soft kev arrows. All controls and measurement functions are contained in the PCB assembly. When turned on, the timer sends a signal to start the pump and the valve motor. The pump sends air through the 2-section valve, which turns and sends air to the two bilateral output ports, filling first the foot and then the calf garments. As the valve continues to rotate the air is released from all chambers at once and the garments deflate. The cvcle repeats three times per minute and default treatment time is one hour, controlled by an internal timer on the PCB.
INDICATIONS FOR USE
The BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: • amputations (minor) • angioplasty/stent failure • arteriopathic wounds . graft failure . intermittent claudication . ischemia . night pain . rest pain . small vessel disease ● ulcers.
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TECHNOLOGICAL CHARACTERISTICS
The manufacturer believes that the technological characteristics of the modified IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System device are substantially similar to those of the predicate IC-BAP BioArterial Plus Arterial Blood Flow Enhancement System. The user interface has been modified from a regulator and analogue pressure gauge in the predicate to a digital pressure sensor and LED display in the applicant device. In place of a manual adjustment knob on the regulator in the predicate device, the pressure can be increased or decreased in increments of 1 mmHg via a soft keypad on the applicant device.
PERFORMANCE DATA
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 cycle profiles (rise times, inflation pressures, deflation times and cycle times) between the applicant and predicate devices.
STATEMENT OF SUBSTANTIAL EQUIVALENCE
Similarities
Both the applicant and the predicate devices provide continuous intermittent pneumatic pressure bilaterally to the foot and calf using inflatable garments. The applicant and predicate devices have the same intended use and indications for use, both operate within the same clinically-established 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 kev 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.
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 K072666IC-BAP BioArterial PlusArterial Blood Flow Enhancement System | DigitalIC-BAP-DL BioArterialPlus Arterial Blood FlowEnhancement System |
|---|---|---|
| Intended Use | The IC-BAP System is intended for theimprovement of blood circulation in thelower extremities to help prevent andreduce complications of poor circulation, byincreasing arterial blood flow through theapplication of bilateral or unilateralintermittent compression to the foot andcalf. The device is intended for home use. | Same |
| Principal of Operation | Intermittent Pneumatic Compression | Same |
| Weight | 7.5 pounds | 7.5 pounds |
| Dimensions, inches | 5 H x 8 W x 12 D | 5 H x 8 W x 8 D |
| # of Segments ingarment(s) | 1 (foot) and 2 (calf) | Same |
| Inflation Time, eachsegment | $4 \pm 0.5$ seconds bilateral | Same |
| Deflation Time | $16 \pm 3$ seconds | Same |
| Delay Time betweenFoot and Calf | $1$ second $\pm 0.5$ seconds | Same |
| Cycle Frequency | 3 cycles per minute | Same |
| RecommendedInflation Pressure | 120 mmHg | Same |
| Treatment Durations | $60 \pm 5$ minutes | same |
| Pressure Adjustment | Locking adjustable knob on regulator | Digital, soft keypad,1mmHg increments |
| Pressure Gauge | 0-125 mmHg, analog | 0 - 150 mmHg, digital |
| Displayed PressureAccuracy | $\pm 10$ mmHg of sleeve pressure,real time pressure displayed on gauge face | $\pm 10$ mmHg of sleevepressure, pressure setpoint displayed on LED |
| Pause time betweeninflation cycles | None (deflation time is pause time) | Same |
| Garments Available | Standard, APG-3045-FC SWide, APG-3045-FCCustom | 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
There is no change in fundamental technology between the IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System and the predicate device. Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the IC-BAP-DL BioArterial Blood Flow Enhancement System is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness. .
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20995-0002
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July 18, 2013
Bio Compression Systems, Inc. C/O Maureen Garner P.O. Box 5374 Toms River. NJ 08754
Re: K131327
Trade/Device Name: IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System
Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: II Product Code: JOW Dated: May 28, 2013 Received: May 29, 2013
Dear Ms. Garner:
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. Isting 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 mav 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Maureen Garner
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
MZillehem
for
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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l. Indications for Use Statement
510(k) Number: K131327
Device Names: IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System
Indications for Use:
The IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:
- Amputations (minor) ●
- Angioplasty / stent failure .
- Arteriopathic wounds .
- Graft failure �
- . Intermittent claudication
- Ischemia ●
- Night pain .
- Rest pain
- Small vessel disease .
- Ulcers .
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann
§ 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).