(126 days)
Not Found
No
The provided text describes a surgical system with various mechanical and fluidic functions, but there is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is a surgical system used for ophthalmic surgery, specifically for performing a vitrectomy. While it aids in a medical procedure, its primary function is surgical intervention rather than direct therapeutic treatment.
No
The device is described as a "surgical system for ophthalmic surgery" that performs functions like "vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction." These are all surgical or treatment functions, not diagnostic ones.
No
The device description clearly outlines a physical system including a console, footswitch, trolley, infusion pole, and various accessories, indicating it is a hardware-based medical device with integrated software for control.
Based on the provided information, the D.O.R.C. Harmony Total Vitrectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy)." This describes a device used during a surgical procedure on a patient's body.
- Device Description: The description details a system that performs surgical functions like cutting, aspiration, illumination, etc., directly on the eye.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The D.O.R.C. Harmony system does not perform these functions.
Therefore, the D.O.R.C. Harmony Total Vitrectomy System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The D.O.R.C. Harmony Total Vitrectomy System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).
Product codes (comma separated list FDA assigned to the subject device)
HQE
Device Description
The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It provides the majority of functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction. The system is operated from one multifunction footswitch which gives the surgeon control over all of the surgical functions.
The D.O.R.C. Harmony Total Vitrectomy System which includes the system, multifunction footswitch, trolley, automatic infusion pole and various sterile and non-sterile accessories provides the majority of functions needed to complete a posterior segment vitrectomy. The system is ac powered and also requires a source of medical grade compressed air to provide for some of the system functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgeon
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.
K961310, K932669/K924222, K961738
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
3/3/99
510(k) Summary Dutch Ophthalmic, USA D.O.R.C. Harmony Total (per 21 CFR 807.92)
SUBMITTER NAME AND ADDRESS 1.
Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848
| Contact Person: | Mark W. Furlong, President |
|---|---|
| Telephone: 603-642-8468 |
Date Prepared: October 26, 1998
2. DEVICE NAME
| Proprietary Name: | D.O.R.C. Harmony Total Vitrectomy System |
|---|---|
| Common/Usual Name: | Vitrectomy System |
| Classification Name: | Vitreous Aspiration & Cutting Instrument |
| (86HOE & 21CFR 886.4150) |
3. PREDICATE DEVICE/S
| Manufacturer | Product Name | 510(k) Number |
|---|---|---|
| Alcon Surgical | Accurus | unknown |
| Storz | Millenium | K961310 |
| MID Labs | SupraVit/VitMate | K932669/K924222 |
| Scieran | Vit Commander | K961738 |
4. DEVICE DESCRIPTION
The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It provides the majority of functions required by the ophthalmic
1
surgeon for performing a vitrectomy including vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction. The system is operated from one multifunction footswitch which gives the surgeon control over all of the surgical functions.
The D.O.R.C. Harmony Total Vitrectomy System which includes the system, multifunction footswitch, trolley, automatic infusion pole and various sterile and non-sterile accessories provides the majority of functions needed to complete a posterior segment vitrectomy. The system is ac powered and also requires a source of medical grade compressed air to provide for some of the system functions.
న. INTENDED USE
The D.O.R.C. Harmony Total Vitrectomy System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
Operational and technological characteristics form the basis for the determination of substantial equivalence of the D.O.R.C. Harmony Total with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation and technological characteristics. The following table summarizes the technological characteristics of the D.O.R.C. Harmony Total in comparison to the predicate devices.
2
| | D.O.R.C. Harmony
Total | Alcon Surgical
Accurus | Storz Millenium | MID Labs
SupraVit/VitMate
Vitreoretinal
System | Scieran
Technologies
Vit Commander |
|--------------------------|-----------------------------------------|----------------------------------------------|-----------------------------------------|---------------------------------------------------------|------------------------------------------|
| 510(k) number | current submission | unknown | K961310 | K932669/K24222 | K961738 |
| Intended Use | Posterior segment
ophthalmic surgery | Posterior segment
ophthalmic surgery | Posterior segment
ophthalmic surgery | Posterior segment
ophthalmic surgery | Posterior segment
ophthalmic surgery |
| Features/Specifications | | | | | |
| Computer Based System | NO | YES | YES | unknown | unknown |
| Vitrectomy | YES | YES | YES | YES | YES |
| type: | guillotine cutter | guillotine or radial
reciprocating cutter | guillotine cutter | guillotine cutter | guillotine cutter |
| drive mechanism: | pneumatic or electric | pneumatic
800 or 1200
cuts/minute | pneumatic | pneumatic | electric |
| maximum cut rate | 800 cuts/minute | | 750 cuts/minute | 800 cuts/minute | 2500 cuts/minute |
| Irrigation/Aspiration | YES | YES | YES | YES | YES |
| aspiration type: | venturi | venturi | venturi | unknown | unknown |
| linear control: | YES | YES | YES | YES | YES |
| maximum vacuum: | 500 mm Hg | 600 mm Hg | 550 mm Hg | 500 mm Hg | 600 mm Hg |
| Phacofragmentation | YES | YES | YES | YES | NO |
| frequency: | 40 kHz | 40 kHz | 28.5 khz | 40 khz | |
| Diathermy | YES | YES | YES | YES | YES |
| frequency: | 13.56 MHz | unknown | unknown | 600 khz | unknown |
| maximum power: | 12 watts | unknown | 7.5 watts | 10 watts | unknown |
| Fiber Optic Light Source | YES | YES | YES | YES | NO |
| dual/single output: | dual | dual | dual | dual | |
| lamp type: | halogen | unknown | unknown | unknown | |
| lamp wattage: | 150 watts | unknown | unknown | unknown | |
| Air Infusion | YES | YES | YES | YES | NO |
| maximum pressure: | 95 mm Hg | 120 mm Hg | 100 mm Hg | 99 mm Hg | |
| Viscous Fluid Injection | YES | YES | NO | NO | NO |
| viscosities: | 1000 or 5000 cs | 1000 or 5000 cs | | | |
| Viscous Fluid Extraction | YES | YES | NO | NO | NO |
| Multifunction Footswitch | YES | YES | YES | YES | YES |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1999
Mr. Mark W. Furlong President Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848
Re: K983797
Trade Name: D.O.R.C. Harmony Total Vitrectomy System Regulatory Class: II Product Code: HQE Dated: February 17, 1999 Received: February 24, 1999
Dear Mr. Furlong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 -Mr. Mark W. Furlong, President
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a Iegally 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
. .. .
The D.O.R.C. Harmony Total vitrectomy system is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Everetta Boom
(Division Sign-Off)
(Division Sign-Off) Division of Ophthalmic Device 510(k) Number.
Prescription Use
(Per 21 CFR 801.109) ✓
Over-The-Counter Use_