(40 days)
The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.
Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.
This document is a 510(k) Premarket Notification for the MID Labs Autonomous Vit Enhancer. It establishes substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or clinical trial data as would be found in a more comprehensive technical report or clinical study summary.
Therefore, many of the requested sections below cannot be populated from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document is a 510(k) Summary and does not contain specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity, throughput) that would typically be reported for a "study." It primarily focuses on comparing features to predicate devices to establish substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: The document does not describe a clinical performance study with a test set. This is a device modification submission, not a new device requiring extensive de novo clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No adjudication method is mentioned as no independent performance study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: This is not an AI device, and no MRMC study or comparative effectiveness study is mentioned. The device is a "Vitreous Aspiration & Cutting Instrument."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is not an algorithm-only device. The device is a "Autonomous Vit Enhancer," which is a stand-alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. Its function is mechanical, not algorithmic for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: No ground truth establishment is mentioned as no independent performance study is described.
8. The sample size for the training set
- Cannot be provided: No training set is mentioned as this device is not a machine learning or AI-based system.
9. How the ground truth for the training set was established
- Cannot be provided: No ground truth for a training set is mentioned.
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APR 2 9 2002
MID Labs Autonomous Vit Enhancer Premarket Notification
510(k) Summary of Safety and Effectiveness
Contact Person:
Linda Upton MID Labs, Inc. 14477 Catalina Street San Leandro, CA 94577 (510) 357-3952
Date Prepared:
| Trade Name: | Autonomous Vit Enhancer |
|---|---|
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument (86 HQE, 21CFR 886.4150) |
Device Description/ Intended Use: Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.
Predicate Device: MID Labs Vit Enhancer™, MID Labs SupraVit® Vitreoretinal Surgical System
Predicate Device Comparison Table
| Device | Autonomous Vit | Vit Enhancer | SupraVit |
|---|---|---|---|
| Description | Enhancer | ||
| 510(k)Number | current | K992943 | K932669 |
| Intended Use | vitreous cutting | vitreous cutting | Posterior segmentophthalmic surgery,including vitreouscutting |
| VitreousCutter Type | guillotine | guillotine | Guillotine |
| User interface | Frequency setting anddisplay on front panel | Frequency setting anddisplay on front panel | Frequency setting anddisplay on front panel |
| Energy source | Internal inputpneumatic energy | External inputpneumatic energy | Internal or externalinput pneumatic energy |
| Internalpressurecontrol | Pressure regulator tocontrol the capturedpneumatic energy | Pressure regulator tocontrol the capturedpneumatic energy | Pressure regulator tocontrol the capturedpneumatic energy |
| Output valvetype | Solenoid valve | Solenoid valve | Solenoid valve |
| Outputfrequencycontrol | Electronic signal at usersettable frequencies | Electronic signal at usersettable frequencies | Electronic signal at usersettable frequencies |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name encircling the perimeter. Inside the circle, there is a stylized representation of three overlapping human figures, symbolizing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2002
Medical Instrument Development Laboratories, Inc. c/o Linda M. Upton 14477 Catalina St. San Leandro, CA 94577
Re: K020911
Trade/Device Name: Autonomous Vit Enhancer Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration & Cutting Instrument Regulatory Class: Class II Product Code: HOE Dated: March 15, 2002 Received: March 20, 2002
Dear Ms. Upton:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Linda M. Upton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure II
Page 32 of 38
510(k) Number (if known):
Device Name: Autonomous Vit Enhancer (AVE)
Indications For Use:
The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | Huynh Hoang |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K020911 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.