(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical compression without mentioning any adaptive or learning capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended as an adjunctive therapy for patients with ischemic disease of the lower extremities."
No
The device description states its purpose is to improve blood circulation and reduce complications of poor circulation, which are therapeutic actions, not diagnostic.
No
The device description explicitly states that the ArterioFlow 7500 consists of a pump, inflatable garments, and tubing, which are all hardware components.
Based on the provided information, the ArterioFlow 7500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "adjunctive therapy for patients with ischemic disease of the lower extremities." It describes a therapeutic intervention (improving blood circulation through compression) rather than a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device (pump, garments, tubing) that applies external compression to the body. This is consistent with a therapeutic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the ArterioFlow 7500 is a therapeutic device designed to improve blood circulation in the lower extremities, not a device used for diagnostic testing outside of the body.
N/A
Intended Use / Indications for Use
The ArterioFlow 7500 is intended as an adjunctive 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 diseas
- Ulcers .
The device is intended for home and hospital use.
Product codes
JOW
Device Description
The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, foot and calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and 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)
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the ArterioFlow 7500 are substantially similar to those of the predicate devices.
List of Performance Tests
PQ-03: Pressure Calibration for Pressure Sensor
PQ-04: Cycle Time Performance
PQ-05: Treatment Time Performance
PQ-06: Pressure Performance of Arterial Garment
PQ-07: Tensile Strength of Arterial Garment
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
510(K) SUMMARY
Submitter:
· Devon Medical, Inc.
Contact Person:
Ruth Wu, COO
1100 First Avenue, Suit 100
King of Prussia, PA 19406
800.571.3135 Phone:
484.636.3380 Fax:
Common Classification & Proprietary Names:
| Common Names: | Sequential Compression Device |
|---|---|
| Proprietary Name: | ArterioFlow 7500 |
Date Prepared:
July 22, 2010
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the ArterioFlow 7500.
| - - - - - - - - - - - -
Production Article
1995 - 1997 - 1997 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
11:40 PM 11
| Submit Comments of Children Research Comments of the Comments of Children
-
- 2435 × 12 × - - - | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----|--|
| . Imh SIPPVP | 870 5800 | IOW | |
- 2435 × 12 × - - - | | |
Predicate Devices:
The ArterioFlow 7500 Sequential Compression Device is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| CircuFlow 5200 | Devon Medical, Inc. | K101523 |
| BioArterial Plus | Bio Compression Systems Inc. | K072666 |
Device Description
The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.
1402582
OCT. 7 2010
1
SECTION 5
Intended Use:
The ArterioFlow 7500 is intended as an adjunctive 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 .
The device is intended for home and hospital use.
Technological Characteristics:
The manufacturer believes that the technological characteristic of the ArterioFlow 7500 are substantially similar to those of the predicate devices. The ArterioFlow 7500 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
Performance Testing
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the ArterioFlow 7500 are substantially similar to those of the predicate devices.
| List of Performance Tests | |
|---|---|
| PQ-03 | Pressure Calibration for Pressure Sensor |
| PQ-04 | Cycle Time Performance |
| PQ-05 | Treatment Time Performance |
| PQ-06 | Pressure Performance of Arterial Garment |
| PQ-07 | Tensile Strength of Arterial Garment |
Standards
The ArterioFlow 7500 conforms to the following standards: UL 60601-1-2 and ISO 14971
Statement of Substantial Equivalence
The ArterioFlow 7500 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, believes that the ArterioFlow 7500, is safe and effective and substantially equivalent to the predicate devices as described herein.
- Ischemia
- Night Pain
- Rest Pain
- Small vessel diseas
- Ulcers
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DCT 7 2010
Devon Medical Inc. c/o Mr. Mark Job Regulatory Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K102582
ArterioFlow 7500 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 7, 2010 Received: September 8, 2010
Dear Mr. Mark Job:
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
3
Page 2 - Mr. Mark Job
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Dmah R. Vahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4
INDICATIONS FOR USE STATEMENT
(102582 510(k) Number (if known):
Device Name: ArterioFlow 7500 Sequential Compression Device
The ArterioFlow 7500 is intended as an adjunctive 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 device is intended for home and hospital use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (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)
AND/OR
brune R. lehner
(D:vi:s
iovascular Devices ( arc
510(k) Number K102582