(165 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a foot-actuated pneumatic device and cuff, with no mention of AI or ML algorithms for image analysis, diagnosis, or any other function.
No.
The device is used to generate static, tourniquet pressure for vascular testing in conjunction with an ultrasound machine, aiding in diagnosis rather than directly treating a condition.
No
The device is an augmentation device that assists in generating waveform images for an ultrasound machine, which is then used in diagnosis. The device itself does not perform diagnosis.
No
The device description explicitly states it is a "foot actuated pneumatic device" that includes an "air bladder cuff," indicating it is a hardware device with mechanical components, not software only.
Based on the provided information, the AugEase™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- AugEase™ Function: The AugEase™ is a device that applies external pressure to a patient's limb using an air bladder cuff. This pressure is used in conjunction with an ultrasound machine to generate waveform images. The device itself does not analyze or test any biological specimens taken from the patient.
- Intended Use: The intended use clearly states it's an "augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing." This is a physical intervention on the patient's body, not an in vitro test.
- Device Description: The description reinforces that it's a "foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb." Again, this describes a physical interaction with the patient.
- Input Imaging Modality: The input is an "Ultrasound imaging machine with or without Doppler," which is an in vivo imaging technique, not an in vitro diagnostic method.
The AugEase™ is an accessory device used to facilitate an in vivo diagnostic procedure (vascular ultrasound). It helps to create the necessary physiological conditions (pressure changes) for the ultrasound machine to capture relevant data, but it does not perform the diagnostic test itself on a biological sample.
N/A
Intended Use / Indications for Use
The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:
- Distal augmentations
- Proximal augmentations
- Reflux measurements of specific venous valves
- Vein Mapping
- Locating suitable distal vessel for bypass
Product codes
JOW
Device Description
The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and defler praced cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging machine with or without Doppler
Anatomical Site
limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Product Validation Testing:
II. Burst pressure; .
III. Materials testing;
Cytotoxicity Test;
Sensitization Test;
Irritation and Intracutaneous Reactivity Test -
Tensile Strength Test;
IV. Method of attachment (Velcro or straps);
V. Seal Strength Comparison;
VI. Cuff Leak Testing;
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary 807.92(c)
OCT 2 6 2010
SPONSOR Company Name:
AUGDVT LLC
Company Address
723 South Casino Center Blvd., 2nd Floor Las Vegas, NV 89101-6716
807.92(a)(1)
Telephone: Fax:
760-744-2882 760-744-2993
Contact Person:
Jeffrey Michaels
Summary Preparation Date: September 14, 2010
DEVICE NAME
807.92(a)(2) Trade Name: AugEase™ Common/Usual Name: Vascular augmentation device Classification Name: Sleeve, Limb, Compressible Regulation Number: 870.8500 Product Code: JOW Device Class: ll Panel: Cardiovascular
PREDICATE DEVICE
Legally Marketed Equivalent Device Company ACI Medical, Inc.
Product Venapulse Models VP-25 & VP-50
510(k) # K903894
DEVICE DESCRIPTION
807.92(a)(4)
807.92(a)(3)
The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and defler praced cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.
1
K101355 pg 2 of 4
DEVICE INTENDED USE
807.92(a)(5)
The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:
- Distal augmentations
- Proximal augmentations ●
- Reflux measurements of specific venous valves ●
- . Vein Mapping
- Locating suitable distal vessel for bypass .
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
PREDICATE PRODUCT COMPARISON
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
| Feature | AUGEASE™ device | VenaPulse Model VP 25 |
|---|---|---|
| Intended use | ||
| and claims | The AugEase™ is a foot actuated | |
| augmentation device intended to | ||
| rapidly inflate and deflate an air | ||
| bladder cuff generating static, | ||
| tourniquet pressure to limbs of | ||
| patients undergoing vascular | ||
| testing. It is indicated as an | ||
| accessory to an ultrasound | ||
| imaging machine with or without | ||
| Doppler which may be used for: | VenaPulse® Model VP-25 | |
| generates static, tourniquet | ||
| pressure to limbs of patients | ||
| undergoing vascular testing. The | ||
| tourniquet pressure is reached | ||
| very rapidly and the tourniquet | ||
| cuff is deflated very rapidly with | ||
| approximately 300 millisecond | ||
| rise and fall times. Inflation and | ||
| deflation are controlled with a | ||
| foot switch or with a manual | ||
| switch. The pressure is regulated | ||
| between 0 and 240mmHg. There | ||
| are safety alarms to ensure safe | ||
| operation. | ||
| Distal augmentations Proximal augmentations Reflux measurements of | ||
| specific venous valves Vein Mapping Locating suitable distal | ||
| vessel for bypass | Indications For Use: Distal augmentations Proximal augmentations Vein mapping Locating suitable distal | |
| vessel for bypass Quantification of venous | ||
| Caution: Federal (USA) law | ||
| restricts this device to sale by or | ||
| on the order of a physician. |
2
K101355 Pg 3 of 4
| flow Reflux measurements of specific venous valves | ||
|---|---|---|
| 510(k) Number | K101355 | K903894 |
| Classification | Compressible Limb Sleeve | Compressible Limb Sleeve |
| Product Code | JOW | JOW |
| Technological | ||
| characteristics | 1. MANUAL |
- PNEUMATIC
- 0.8L MAXIMUM VOLUME
- RAPID INFLATION CUFF
- LARGE DIAMETER HOSE | 1. ELECTRIC
- COMPUTER AUTOMATION
- PNEUMATIC
- UNKNOWN MAXIMUM VOLUME
- RAPID INFLATION CUFF
- LARGE DIAMETER HOSE |
| Mode of
operation | Rapid inflation and deflation
Foot actuated | Rapid inflation and deflation
Foot switch/manual switch |
| Inflation/deflation rise and fall
time | 0.5 seconds | 300 millisecond |
| Pressure | 0-240mm/Hg | 0-240mmHg |
| Safety feature | 1. Check Valve 1.0 psi - 300mm/Hg Gauge | 1. Alarm |
| Instructions for
use | yes | yes |
| Non-sterile | yes | yes |
NONCLINICAL AND CLINICAL TEST
807.92(b)
Product Validation Testing:
II. Burst pressure; .
III. Materials testing;
Cytotoxicity Test; ।
Sensitization Test; י
Irritation and Intracutaneous Reactivity Test -
Tensile Strength Test; ।
IV. Method of attachment (Velcro or straps);
V. Seal Strength Comparison;
VI. Cuff Leak Testing;
3
SAFETY and EFFECTIVENESS
The AugEase™ Vascular is similar to the predicate device in intended use and mode of operation. The AugEase™ is a manually operated device and does not raise any new issue of safety and effectiveness.
K1013
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AugDVT LLC c/o Mr. E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114
OCT 2 6 2010
Re: K101355
Trade/Device Name: AugEase™ Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 14, 2010 Received: September 14, 2010
Dear Mr. Smith:
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.
5
Page 2 - Mr. E. J. Smith
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 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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Palmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
Indications for Use
510(k) Number (if known): K101355
OCT 2 6 2010
Device Name: AugEase™
Indications for Use:
The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:
- Distal augmentations .
- Proximal augmentations .
- Reflux measurements of specific venous valves .
- Vein Mapping
- Locating suitable distal vessel for bypass .
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page __ 1 _ of _ 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DMR. KULNER
(Division Sign-Off)
Division of Cardiovascular Devices
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