(50 days)
Not Found
No
The device description details a pneumatic compression system with mechanical and electronic components for sequential inflation and deflation. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristics typically associated with AI/ML. The control system appears to be based on pre-set parameters and user adjustments, not intelligent algorithms.
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," and "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." These are all therapeutic applications.
No
The device is described as a sequential, pneumatic compression device intended for treatment, not for diagnosis.
No
The device description explicitly details physical components such as AC-powered pumps, inflatable garments, flexible tubing, a compressor, a rotating disc valve, a digital pressure sensor, and a durable plastic housing. It also describes mechanical actions like sequential inflation and deflation of chambers. This indicates a hardware-based medical device with integrated software for control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "primary or adjunctive treatment of primary or secondary lymphedema," "additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers," and "general treatment for swelling of the extremities." These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details a pneumatic compression device that applies external pressure to the body. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: The text does not mention any components or processes related to in vitro testing, such as reagents, assays, sample collection, or laboratory analysis.
In summary, the device is a therapeutic medical device used for physical treatment, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Bio Compression Systems' SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These 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 (comma separated list FDA assigned to the subject device)
JOW
Device Description
The devices consist of AC-powered pumps and inflatable garments connected by flexible tubing. The pumps consist of a compressor capable of a maximum pressure of 150 mmHg, a rotating disc valve driven by a motor and a digital pressure sensor, housed in durable plastic, Moving parts are not accessible to the user. The garments consist of four (SC-3004-DL and SC-3004FC-DL) or eight (SC-2008-DL and SC-3008-DL) discrete inflatable chambers, attached to the pump via tubing, and are applied externally over the affected limb or torso. Unilateral or bilateral limb treatment can be applied. Unique connector fittings on the tubing prevent accidental and incorrect pump/garment combinations or use with garments or sleeves from other manufacturers.
The system provides gradient pressurization to the chambers, i.e., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the 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 chambers are inflated, the pressure is released in all chambers simultaneously, and the cycle repeats. The SC-3004-DL provides a 90-second inflation/deflation cycle, while the SC-3008-DL, SC-2008-DL and SC-3004FC-DL models provide 50-second cycles. The SC-3004FC-DL model is "fast cycle" and use the faster (8-chamber device) motor to turn the valve, providing faster cycle times for the four-chamber models.
Operating pressure is 30 to 120 mmHg. Pressure is pre-set at the factory to 60 mmHg (distal) with a decreasing distal-to-proximal gradient of 1 mmHg per chamber. The compressor is capable of no more than 150 mmHg pressure, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP and DOWN pressure button arrows. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off according to the pump pressure setting, and an LED panel displays the set pressure and displays "0" during the deflation cycle. In the SC-2008-DL device, the UP and DOWN pressure buttons allow the user to change the pressure in the distal chamber, and the decreasing 1 mmHg/chamber gradient is maintained throughout the remaining chambers. The SC-3004-DL. SC-3004FC-DL and SC-3008-DL models have the same feature but additionally provide a means to change the individual chamber pressures in the gradient. The software prevents reverse gradient adjustments.
When the garments are inflated, they compress the limb and help to move lymph away from the extremities and/or torso so it can be eliminated by the body. Garments are available in sizes to accommodate varying limb lengths and girth, and custom garments can be provided. The SC-3004-DL and SC-3004FC-DL systems have four-chamber garments, and the SC-2008-DL and SC-3008-DL systems have eight-chamber garments. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. Instructions are provided for the patient to attach the garments and perform therapy at home after a physician has prescribed treatment and the patient has been oriented and educated on proper use of the device.
The user interface consists of UP and DOWN pressure adjustment arrows (buttons). All controls and measurement functions are integrated into 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 valve, which turns and sends air to the output ports, filling each garment chamber sequentially. As the valve continues to rotate the air is released from all chambers at once and the garment deflates. The cycle repeats every 90 seconds for the SC-3004-DL or every 50 seconds for the SC-2008-DL, SC-3008-DL and 3004FC-DL. Treatment duration is prescribed by the physician, and typically is two one-hour sessions per day.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected limb or torso, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 chamber, air pressure display accuracy, and inflation/deflation cycle times. The results demonstrate inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times) between the applicant and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Bio Compression Systems, Inc. Barbara Whitman Director, RA & QA 120 West Commercial Ave. Moonachie, New Jersey 07074
Re: K142640
Trade/Device Name: Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequential Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 16, 2014 Received: September 17, 2014
Dear Ms. 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, 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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,
M.A. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
I. Indications for Use Statement
510(k) Number: Unknown K142640
Device Names: Bio Compression Systems Sequential Circulator digital series model numbers SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL.
Indications for Use:
The Bio Compression Systems' SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These 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.
Prescription Use Over-The-Counter Use x - 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)
3
II. 510(k) Summary
APPLICANT'S INFORMATION:
Barbara Whitman, Director, RA & QA Bio Compression Systems, Inc 120 West Commercial Avenue Moonachie, NJ, 07074 PH: 201 340-6422 FX: 201 939-4503 E-mail: barbaraw@biocompression.com http://www.biocompression.com Internet: Medical Establishment Registration No .: 2424387
SUBMITTER'S INFORMATION Same as Applicant
DATE: September 16, 2014
DEVICE INFORMATION
| DEVICE NAME: | SC-3008-DL Sequential Circulator
SC-3004-DL Sequential Circulator
SC-3004FC-DL Sequential Circulator
SC-2008-DL Sequential Circulator |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Panel: | Cardiovascular and Respiratory Devices |
| Classification Number: | 870.5800 |
| Product Nomenclature: | Compressible Limb Sleeve |
| Product Code: | JOW |
| Trade/Proprietary Name: | SC-3008-DL, SC-3004-DL, SC-3004FC-DL, SC-2008-DL
Sequential Circulators |
| Common Name: | SC-3008-DL, SC-3004-DL, SC-3004FC-DL, SC-2008-DL
Sequential Circulators |
DEVICE CLASSIFICATION
Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular and Respiratory Devices.
PREDICATE DEVICE
The predicate device is the SC-3008 Sequential Circulator, K043423
DEVICE DESCRIPTION
The devices consist of AC-powered pumps and inflatable garments connected by flexible tubing. The pumps consist of a compressor capable of a maximum pressure of 150 mmHg, a rotating disc valve driven by a motor and a digital pressure sensor, housed in durable plastic, Moving parts are not accessible to the user. The garments consist of four (SC-3004-DL and SC-3004FC-DL) or eight (SC-2008-DL and SC-3008-DL) discrete inflatable chambers, attached to the pump via tubing, and are applied externally over the affected limb or torso. Unilateral or bilateral limb treatment can be applied. Unique connector fittings on the tubing prevent accidental and incorrect pump/garment combinations or use with garments or sleeves from other manufacturers.
ી રે
4
The system provides gradient pressurization to the chambers, i.e., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the 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 chambers are inflated, the pressure is released in all chambers simultaneously, and the cycle repeats. The SC-3004-DL provides a 90-second inflation/deflation cycle, while the SC-3008-DL, SC-2008-DL and SC-3004FC-DL models provide 50-second cycles. The SC-3004FC-DL model is "fast cycle" and use the faster (8-chamber device) motor to turn the valve, providing faster cycle times for the four-chamber models.
Operating pressure is 30 to 120 mmHg. Pressure is pre-set at the factory to 60 mmHg (distal) with a decreasing distal-to-proximal gradient of 1 mmHg per chamber. The compressor is capable of no more than 150 mmHg pressure, making the device intrinsically safe. Pressure can be adjusted up or down in increments of 1 mmHg with the UP and DOWN pressure button arrows. The pressure is regulated by a digital pressure sensor that turns the air compressor pump on and off according to the pump pressure setting, and an LED panel displays the set pressure and displays "0" during the deflation cycle. In the SC-2008-DL device, the UP and DOWN pressure buttons allow the user to change the pressure in the distal chamber, and the decreasing 1 mmHg/chamber gradient is maintained throughout the remaining chambers. The SC-3004-DL. SC-3004FC-DL and SC-3008-DL models have the same feature but additionally provide a means to change the individual chamber pressures in the gradient. The software prevents reverse gradient adjustments.
When the garments are inflated, they compress the limb and help to move lymph away from the extremities and/or torso so it can be eliminated by the body. Garments are available in sizes to accommodate varying limb lengths and girth, and custom garments can be provided. The SC-3004-DL and SC-3004FC-DL systems have four-chamber garments, and the SC-2008-DL and SC-3008-DL systems have eight-chamber garments. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Velcro fasteners support garment application. Instructions are provided for the patient to attach the garments and perform therapy at home after a physician has prescribed treatment and the patient has been oriented and educated on proper use of the device.
The user interface consists of UP and DOWN pressure adjustment arrows (buttons). All controls and measurement functions are integrated into 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 valve, which turns and sends air to the output ports, filling each garment chamber sequentially. As the valve continues to rotate the air is released from all chambers at once and the garment deflates. The cycle repeats every 90 seconds for the SC-3004-DL or every 50 seconds for the SC-2008-DL, SC-3008-DL and 3004FC-DL. Treatment duration is prescribed by the physician, and typically is two one-hour sessions per day.
INDICATIONS FOR USE
The Bio Compression Systems' SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These 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.
5
TECHNOLOGICAL CHARACTERISTICS
The manufacturer believes that the technological characteristics of the modified (digital) SC-3008-DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL Sequential Circulators are substantially similar to those of the predicate (analogue) device. The user interface has been modified from a rocker on/off switch, pressure-control dial and analogue needle pressure gauge in the predicate device to pressure contact buttons and an LED display in the applicant devices. In place of a manual adjustment dial on the regulator in the predicate device, the pressure can be increased or decreased in increments of 1 mmHg via the UP and DOWN pressure buttons on the applicant devices.
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 chamber, air pressure display accuracy, and inflation/deflation cycle times. The results demonstrate 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 sequential inflation pressure from distal to proximal chambers and have the same intended use and indications for use and all devices operate within the same clinically-established parameters. Both the applicant and predicate devices offer adjustable pressure ranges. The predicate device is an eight-chamber system. and the SC-2008-DL and SC-3008-DL are also eight chamber systems and use the same garments. The applicant and predicate devices use the same prescribed inflation pressures, inflation and deflation times and have an internal one-hour timer for treatment duration.
Differences
The applicant devices are controlled via a PCB that includes a digital pressure sensor and LED pressure display, while the predicate device utilizes an analogue needle gauge display. The applicant devices have up and down pressure contact buttons (arrows) to adjust pressure up or down, while the predicate has a locking pressure control knob attached to a regulator. In the predicate device, the individual gradient pressures are adjusted by screws on the bottom of the pump, while on the applicant devices, gradient pressures are adjusted using the pressure UP/DOWN arrows after entering an access sequence on the contact pressure buttons. (Note: only the SC-2008-DL does not have an option for adjusting the individual gradient pressures.)
The predicate device is an eight-chamber system, while the SC-3004-DL and SC-3004FC-DL are four-chamber systems and use four-chamber garments.
The predicate device has a replaceable fuse, which is accessible by the user, while the applicant devices have internal fuses that are not user-accessible. The applicant SC-3008-DL has a "Pretreatment Mode" option, where the three most proximal chambers will cvcle for 10 minutes prior to engaging all eight chambers. This mode is thought to mimic manual massage and help relieve congestion in the proximal areas, thus facilitating the movement of lymph in the more distal areas. The predicate device and the SC-3004-DL, SC-3004FC-DL and SC-2008-DL do not have a Pretreatment Mode option. The applicant devices have a continuous mode option, while the predicate device does not have a continuous mode option and must be turned off manually.
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:
6
| Parameter | SC-3008-DL | SC-3004-DL | SC-3004FC-DL | SC-2008-DL | Predicate
SC-3008 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|-----------------------------|--------------------------------|
| Intended Use | Intended for the primary or adjunctive treatment of primary or secondary
lymphedema. 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. For home or hospital use. | | | | |
| Principal of
Operation | Sequential pneumatic compression | | | | |
| Weight | 5.5 pounds | 5.5 pounds | 5.5 pounds | 5.5 pounds | 8 pounds |
| Dimensions,
inches | 4.5H x 11.75W
x 7.75D | 4.5H x 11.75W
x 7.75D | 4.5H x 11.75W
x 7.75D | 4.5H x 11.75W
x 7.75D | 5.5H x 12W x
8D |
| # of Chambers in
garment | 8 | 4 | 4 | 8 | 8 |
| Sequential
chamber inflation | Yes | | | | |
| Distal/Proximal
gradient | Yes | | | | |
| Pressure
adjustment | | | | | Analogue dial
and regulator |
| Pressure Control | | Solenoid | | Compressor
on/off cycles | Regulator |
| Pressure Gauge | | | | | 0-125 mmHg
Analogue |
| Inflation Pressure | 30 - 125 mmHg distal, adjustable in 1 mmHg increments | | | | |
| Inflation Time,
each chamber | 5.5 seconds | 18 seconds | 5.5 seconds | 5.5 seconds | 5.5 seconds |
| Deflation Time
(All chambers
simultaneously) | 5.5 seconds | 18 seconds | 5.5 seconds | 5.5 seconds | 5.5 seconds |
| Total Cycle Time | 50 seconds | 90 seconds | 50 seconds | 50 seconds | 50 seconds |
| Garments
Available | 8 chamber
arm/leg/torso | 4 chamber
arm/leg/torso | 4 chamber
arm/leg/torso | 8 chamber
arm/leg/torso | 8 chamber
arm/leg/torso |
| Fail-safe hose
connectors | Yes | | | | |
| Uni/Bilateral Use | Yes | | | | |
| On-board 1 hour
session timer | Yes | | | | |
| Pretreatment
Mode | Yes | No | No | No | No |
| Logs Total Use
Hours | Yes | Yes | Yes | Yes | No |
| Replaceable
Outer Fuse | No | No | No | No | Yes |
| Power Source | 115VAC, 50-60Hz | | | | |
|
| Table of Similarities and Differences with the Predicate Device | |
|---|---|
| Company of the consideration of the commend to the commend of the comments of the comments of the comments of the comments of the comments of the comments of the comments of |
CONCLUSION
There is no change in fundamental technology between the SC-3008-DL, SC-3004FC-DL and SC-2008-DL Sequential Circulators and the predicate device. Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate device, the manufacturer believes that the SC-3008-DL, SC-3004FC-DL and SC-2008-DL Sequential Circulators are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.