(32 days)
Not Found
No
The device description explicitly states the pump is manual with constant cycle times and pre-set pressure, and there is no mention of AI or ML in the document.
Yes
The device is intended for the prophylaxis of deep vein thrombosis, enhancement of circulation, prevention/healing of ulcers, and reduction of edema and pain, which are all therapeutic purposes. Its mechanism involves physical compression to achieve these clinical benefits.
No.
The device is intended for therapeutic purposes such as deep vein thrombosis (DVT) prophylaxis, enhancement of circulation, and reduction of edema and pain, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a pump, inflatable garments, and interconnection tubing, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an external compression system used to prevent deep vein thrombosis and improve circulation. It works by applying pressure to the lower extremities.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It interacts with the patient externally.
Therefore, this device falls under the category of a therapeutic or prophylactic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JOW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calves, calves and thighs, feet, lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and home 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932900, K965153, K881632, K043423
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
K061857
Page 1 of 3
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.
-
- 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
-
- DEVICE CLASSIFICATION: Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.
1
K061857
Page 2 of 3
-
- PREDICATE DEVICE(s):
7. DEVICE DESCRIPTION:
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.
2
K061857
Page 3 of 3
-
- 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
-
- 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.
-
- PERFORMANCE DATA:
Performance testing was performed and assures that the product meets its specifications.
- PERFORMANCE DATA:
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.
-
- 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.
- STATEMENT OF SUBSTANTIAL EQUIVALENCE:
3
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
4
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
5
510(k) Number (if known):
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