(42 days)
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No
The summary describes a mechanical lift for transporting individuals and contains no mention of AI, ML, or related concepts.
No
The device is a lift intended for mechanically transporting individuals, not for treating a medical condition or disease.
No
The intended use statement describes mechanical transport for individuals with mobility disabilities, not diagnosis. It facilitates movement rather than identifying or characterizing a medical condition.
No
The intended use clearly describes a device that mechanically transports an individual, which implies a physical, hardware-based system, not software alone.
Based on the provided information, the VPL-3100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "mechanically transport an individual with a mobility disability...from one level to another in a private residence." This describes a physical function related to mobility, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
The VPL-3100 appears to be a mobility aid or lift, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The VPL-3100 is intended to mechanically transport an individual with a mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
Product codes
ING
Device Description
Bruno Vertical Platform Lift, VPL-3100
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human figures arranged in a row, with each figure slightly overlapping the one in front of it. The figures are depicted in a simple, abstract manner, and they are all facing the same direction.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2006
Bruno Independent Living Aids, Inc. % Mr. Terrence O'Brien 1780 Executive Drive Oconomowoc, Wisconsin 53066
Re: K061514
Trade/Device Name: Bruno Vertical Platform Lift, VPL-3100 Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulation Class: II Product Code: ING Dated: May 26, 2006 Received: June 1, 2006
Dear Mr. O'Brien:
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.
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
1
Page 2 - Mr. Terrence O'Brien
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Heilutermans
/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
FDA 510(k) Submittal VPL-3100 Medical Device
Statement of Indications for Use 4
510(k) Number (if known): K061514
Device Name:
Bruno Vertical Platform Lift, VPL-3100
Elevator, Wheelchair
Indications for Use:
The VPL-3100 is intended to mechanically transport an individual with a mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Leun
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number Ko61514