(40 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's function in conjunction with existing surgical equipment.
Yes
The device is used to remove vitreous and intraocular tissue, which is a therapeutic intervention. Its intended use is in conjunction with surgical equipment for direct medical treatment.
No
The device description states its use is "to remove vitreous and intraocular tissue," which describes a surgical or therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "stand alone console box with accessories," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove vitreous and intraocular tissue" in conjunction with ophthalmic surgical equipment. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description confirms it's a "stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting." This further reinforces its role in a surgical procedure.
- Anatomical Site: The anatomical site is "intraocular," meaning inside the eye. This is a direct interaction with the patient's body.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HOE
Device Description
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.
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
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.)
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
§ 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.
0
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 segment |
| ophthalmic surgery, | |||
| including vitreous | |||
| cutting | |||
| Vitreous | |||
| Cutter Type | guillotine | guillotine | Guillotine |
| User interface | Frequency setting and | ||
| display on front panel | Frequency setting and | ||
| display on front panel | Frequency setting and | ||
| display on front panel | |||
| Energy source | Internal input | ||
| pneumatic energy | External input | ||
| pneumatic energy | Internal or external | ||
| input pneumatic energy | |||
| Internal | |||
| pressure | |||
| control | Pressure regulator to | ||
| control the captured | |||
| pneumatic energy | Pressure regulator to | ||
| control the captured | |||
| pneumatic energy | Pressure regulator to | ||
| control the captured | |||
| pneumatic energy | |||
| Output valve | |||
| type | Solenoid valve | Solenoid valve | Solenoid valve |
| Output | |||
| frequency | |||
| control | Electronic signal at user | ||
| settable frequencies | Electronic signal at user | ||
| settable frequencies | Electronic signal at user | ||
| settable frequencies |
1
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.
2
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
3
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)