(50 days)
No
The device description details a manual, pneumatic compression system with user-adjustable pressure settings and fixed cycle times. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI or ML. The control is entirely manual and based on fixed parameters.
Yes
The device is intended for the treatment of various medical conditions such as lymphedema, venous insufficiency, and chronic venous stasis ulcers, which directly aligns with the definition of a therapeutic device.
No
The device is described as a treatment device for lymphedema, venous insufficiency, chronic venous stasis ulcers, and swelling of the extremities, not for diagnosis.
No
The device description clearly outlines physical components such as a manual pump, compressor, calibrated dial gauge, and inflatable sleeves/garments. This indicates it is a hardware-based medical device with some manual controls, not a software-only device.
Based on the provided information, the Model SC-3008 Sequential Circulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device is a pneumatic compression device that is applied externally to the extremities.
- The intended use and device description clearly indicate a physical therapy/rehabilitation application. It treats conditions like lymphedema, venous insufficiency, and swelling through external compression.
- There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Model SC-3008 Sequential Circulator falls under the category of a physical medicine or rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is 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 of swelling of the extremities. The device is intended for home or hospital use.
Product codes
JOW
Device Description
The device consists of a manual pump (e.g., the user manually adjusts the pressures, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing discrete, segmented inflatable chambers externally applied over the affected extremity. The pump consists of a compressor capable of a maximum pressure of 150mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). . A calibrated dial gauge displays pressure in the range of 0-125mmHg.
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, they are then all released simultaneously, and the cycle repeats. Pressures within the chambers are adjustable - pressure to chambers 1 &2 is controlled by a user-adjusted regulator on the pump. Pressure in chambers 384, 5&6, and 7&8 can be individually lowered from the default factory settings.
Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:
Arm - Small, Leg - Small, Leg - Adjustable Small
Arm - Medium, Leg - Medium, Leg - Adjustable Medium
Arm - Large, Leg - Large, Leg - Adjustable Large
Arm - w/ Shoulder, Arm - Custom, Leg - Custom
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance testing was performed and assures that the product meets its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K810338 Lymphapress, The Sequential Circulator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB - 1 2005
Image /page/0/Picture/1 description: The image shows the logo for Bio Compression Systems Inc. The logo is black and white and features a series of vertical lines on either side of the text. The text is stacked and reads "BIO COMPRESSION SYSTEMS INC."
201-939-0716 _ 800-888-0908 _ Fax: 201-939-4503 120 W. Commercial Avenue, Moonachie, NJ 07074
510(k) Summary Model SC-3008 Sequential Circulator 510(k) Number Ko 4342 3
Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
-
- APPLICANT'S INFORMATION: Ron Motherwell Executive Vice President 201 939-0716 PH: 201 939-4503 FX: http://www.biocompression.com Internet: Medical Establishment 2424387 Registration No.:
-
- SUBMITTER'S INFORMATION James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44141 440 546.4936 PH/FX: 724 7.13.2298 Mobile: coastalcg@earthlink.net E-mail: http://www.coastalcg.com Internet:
- ന് Date:
November 27, 2004
| 4. DEVICE INFORMATION | |
|---|---|
| DEVICE NAME: | Model SC-3008 Sequential Circulator |
| Classification Panel: | Cardiovascular and Respiratory Devices |
| Classification Number: | 870.5800 |
| Product Nomenclature: | Compressible Limb Sleeve |
| Product Code(s): | JOW |
| Trade/Proprietary Name: | Model SC-3008 Sequential Circulator |
| Common Name: | Model SC-3008 Sequential Circulator |
5. DEVICE CLASSIFICATION: Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.
-
- PREDICATE DEVICE(s):
- K810338 Lymphapress .
- (Pre-amendments) The Sequential Circulator .
1
7. DEVICE DESCRIPTION:
The device consists of a manual pump (e.g., the user manually adjusts the pressures, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing discrete, segmented inflatable chambers externally applied over the affected extremity. The pump consists of a compressor capable of a maximum pressure of 150mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). . A calibrated dial gauge displays pressure in the range of 0-125mmHg.
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, they are then all released simultaneously, and the cycle repeats. Pressures within the chambers are adjustable - pressure to chambers 1 &2 is controlled by a user-adjusted regulator on the pump. Pressure in chambers 384, 5&6, and 7&8 can be individually lowered from the default factory settings.
Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:
| Arm - Small | Leg - Small | Leg - Adjustable Small |
|---|---|---|
| Arm - Medium | Leg - Medium | Leg - Adjustable Medium |
| Arm - Large | Leg - Large | Leg - Adjustable Large |
| Arm - w/ Shoulder | Arm - Custom | Leg - Custom |
8. INDICATIONS FOR USE:
The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device intended for the primary or adjunctive \ treatment of primary or secondary lymphedema. The device is 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 of swelling of the extremities. The device is intended for home or hospital use.
9. TECHNOLOGICAL CHARACTERISTICS:
The manufacturer believes that the technological characteristics of the Model SC-3008 Sequential Circulator are substantially similar to those of the predicate devices.
10. PERFORMANCE DATA:
Performance testing was performed and assures that the product meets its specifications.
11. STATEMENT OF SUBSTANTIAL EQUIVALENCE:
Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the Model SC-3008 Sequential Circulator is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains an eagle-like bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.
Public Health Service
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio Compression Systems, Inc. c/o Ned Devine Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548
K043423 Re:
Model SC-3008 Sequential Circulator Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 10, 2004 Received: December 13, 2004
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Ned Devine
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. buchares DWVWA
Image /page/3/Picture/5 description: The image shows a black and white drawing of a symbol. The symbol is abstract and appears to be a stylized letter or character. It has curved lines and sharp angles, creating a unique and somewhat complex design. The symbol is the only element in the image, set against a plain white background.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K043423
Device Name: Model SC-3008 Sequential Circulator
Indications for Use:
The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is 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 of swelling of the extremities. The device is intended for home or hospital use.
Prescription Use X (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)
DURING lectures
ESEN Sign-Off) SION of Cardiovascular Devices
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