(205 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and do not mention any computational or data-driven components indicative of AI/ML.
No
The device is intended to assist with refilling a liquid oxygen tank and does not directly provide a therapeutic effect to the patient. It's a support tool for the oxygen tank.
No
The device is described as an assistive tool for refilling portable liquid oxygen tanks, focusing on mechanical support and liquid transfer, not on diagnosing medical conditions or diseases.
No
The device description clearly outlines physical components like a telescoping spring arm assembly, fiberglass base plate, and pivot, indicating it is a hardware device with a mechanical function.
Based on the provided information, the EZ-ASSIST-FILL device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist with refilling a portable liquid oxygen tank. This is a physical process involving medical equipment (oxygen tanks), not a diagnostic test performed on biological samples.
- Device Description: The device is a mechanical support system designed to hold and position oxygen tanks. It does not involve any reagents, assays, or analysis of biological materials.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to diagnostic markers, disease detection, or any other typical IVD functions.
The EZ-ASSIST-FILL is a medical device, but it falls under a different category than In Vitro Diagnostics. It's a device that aids in the use of another medical device (the oxygen tank).
N/A
Intended Use / Indications for Use
EZ-ASSIST-FILL is intended to assist the user with refilling a portable liquid oxygen tank. The device is for use in homes or clinics.
The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.
Product codes (comma separated list FDA assigned to the subject device)
PCM
Device Description
EZ-ASSIST-FILL is designed to support any combination of portable and reservoir units that use downward pressure to effect the transfer connection. EZ-ASSIST-FILL consists of a telescoping spring arm assembly mounted on a fiberglass base plate using pivot which allows the spring arm to rotate through 90 degrees to swing over the portable unit when in refill position. The entire unit is held in place by the weight of the reservoir, which rests entirely on the base plate. There is no need to remove the reservoir from EZ-ASSIST-FILL between uses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user / homes or clinics
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
Bench testing was performed to assess functionality of the EZ-ASSIST-FILL. The EZ-ASSIST-FILL devices were tested according to the "EZ-ASSIST-FILL Production Unit Repeatability Test". The devices met the requirements of the predetermined acceptance criteria, which confirmed that the EZ-ASSIST-FILL held the portable oxygen tank in place without any manual intervention and the portable tank was successfully filled when using the EZ-ASSIST-FILL. All devices passed the test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to assess functionality of the EZ-ASSIST-FILL. The EZ-ASSIST-FILL devices were tested according to the "EZ-ASSIST-FILL Production Unit Repeatability Test". The devices met the requirements of the predetermined acceptance criteria, which confirmed that the EZ-ASSIST-FILL held the portable oxygen tank in place without any manual intervention and the portable tank was successfully filled when using the EZ-ASSIST-FILL. All devices passed the test.
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
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: k121661_.
DEC 2 7 2012
Submitter's Identification: 1.
Mr. Peter Glassberg Assist Fill, LLC 7143 NW 67 Way Parkland, FL 33067 Tel: 954-232-8676
Date Summary Prepared: December 17, 2012
Name of the Device: EZ-ASSIST-FILL 2.
- Common or Usual Name: Daily Activity Assist Device 3. Classification: 21 CFR 890.5050 product code: PCM
Predicate Device Information: · 4.
Puritan-Bennett Helios Universal, cleared under K993220 Fred Sammons Inc. Jar Holder & Opener cleared under K813631
ડ. Device Description:
EZ-ASSIST-FILL is designed to support any combination of portable and reservoir units that use downward pressure to effect the transfer connection. EZ-ASSIST-FILL consists of a telescoping spring arm assembly mounted on a fiberglass base plate using pivot which allows the spring arm to rotate through 90 degrees to swing over the portable unit when in refill position. The entire unit is held in place by the weight of the reservoir, which rests entirely on the base plate. There is no need to remove the reservoir from EZ-ASSIST-FILL between uses.
Intended Use: Q.
EZ-ASSIST-FILL is intended to assist the user with refilling a portable liquid oxygen tank. The device is for use in homes or clinics.
l
The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.
1
Technological Comparison to Predicate Devices: 7.
- The device performs the same function as a person applying pressure during filling. The only difference is that the assist device arm needs to be moved into position to hold the oxygen unit in place during filling.
The EZ-ASSIST-FILL is designed with similar intent as Fred Sammons Inc. Jar Holder & Opener that being to hold an object in place replacing the required user physical strength to achieve the same end results without using the assist device.
The predicate is mounted to a flat, stationary workspace in order to provide assistance holding the jar in place while the person opens a jar, while the subject device is mounted on to the reservoir tank to provide assistance holding the lever in place while the user fills the tank.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:
Bench testing was performed to assess functionality of the EZ-ASSIST-FILL. The EZ-ASSIST-FILL devices were tested according to the "EZ-ASSIST-FILL Production Unit Repeatability Test". The devices met the requirements of the predetermined acceptance criteria, which confirmed that the EZ-ASSIST-FILL held the portable oxygen tank in place without any manual intervention and the portable tank was successfully filled when using the EZ-ASSIST-FILL. All devices passed the test.
Discussion of Clinical Tests Performed: 9.
Clinical testing was not performed.
10. Conclusions:
Based on the information provided in this submission we conclude that the EZ-ASSIST-FILL is substantially equivalent to the predicates and is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
December 27, 2012
Assist Fill, Limited Liability Company C/O Ms. Maria F. Griffin MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 GREAT NECK NY 11021
Re: K121661
Trade/Device Name: EZ-Assist-Fill Regulation Number: 21 CFR 890.5050 Regulation Name: Daily Activity Assist Device Regulatory Class: I Product Code: PCM Dated: December 17, 2012 Received: December 20, 2012
Dear Ms. Griffin:
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.
3
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 devicerelated 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,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 1
Indications for Use
of 1 Page _
510(k) Number (if known):
Device Name
EZ-ASSIST-FILL
Indications For Use:
EZ-ASSIST-FILL is intended to assist the user with refilling the portable liquid oxygen tank. The device is for use in homes or clinics.
The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
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)
Nayan J. Patel -S 2012.12.27 12:10:33,-05'00
For Lex Schultheis
(Division Sign-Off) (Division Sigir-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number:_K121661