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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).
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.
The provided text is a 510(k) premarket notification for the D.O.R.C. Harmony Total Vitrectomy System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic or AI-powered medical device.
Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission.
The "study" in this context is the comparison of technological characteristics of the D.O.R.C. Harmony Total Vitrectomy System to its predicate devices. The acceptance criteria are implicit in the FDA's "substantial equivalence" determination, meaning the new device must be as safe and effective as a legally marketed predicate device.
Here's an breakdown based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, there isn't a formally stated "acceptance criteria" in terms of specific performance metrics with PASS/FAIL thresholds for a novel diagnostic. Instead, the acceptance criteria are satisfied by demonstrating that the new device's technological characteristics are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the listed specifications of the D.O.R.C. Harmony Total Vitrectomy System, as compared to the predicate devices.
| Feature/Specification | Acceptance Criteria (Implicit: Comparable to Predicate) | D.O.R.C. Harmony Total Performance | Predicate Devices (Range/Example) |
|---|---|---|---|
| Intended Use | Posterior segment ophthalmic surgery | Posterior segment ophthalmic surgery | Same |
| Vitrectomy Type | Guillotine cutter (or equivalent) | Guillotine cutter | Guillotine or radial reciprocating |
| Vitrectomy Drive Mechanism | Pneumatic or electric | Pneumatic or electric | Pneumatic |
| Maximum Cut Rate | Comparable to predicate devices | 800 cuts/minute | 750 - 2500 cuts/minute (predicates show a range) |
| Aspiration Type | Venturi (or equivalent) | Venturi | Venturi |
| Linear Control | Present | YES | YES |
| Maximum Vacuum | Comparable to predicate devices | 500 mm Hg | 500 - 600 mm Hg |
| Phacofragmentation | Present (if predicate has it) | YES | YES |
| Phaco Frequency | Comparable to predicate devices | 40 kHz | 28.5 kHz - 40 kHz |
| Diathermy | Present (if predicate has it) | YES | YES |
| Diathermy Frequency | Comparable to predicate devices | 13.56 MHz | 600 kHz (one predicate) |
| Diathermy Max Power | Comparable to predicate devices | 12 watts | 7.5 - 10 watts |
| Fiber Optic Light Source | Present (if predicate has it) | YES | YES |
| Light Output | Dual/Single | Dual | Dual |
| Lamp Type | Halogen (or equivalent) | Halogen | Unknown for predicates |
| Lamp Wattage | Comparable to predicate devices | 150 watts | Unknown for predicates |
| Air Infusion | Present (if predicate has it) | YES | YES |
| Air Infusion Max Pressure | Comparable to predicate devices | 95 mm Hg | 99 - 120 mm Hg |
| Viscous Fluid Injection | Present (if predicate has it) | YES | NO (for Storz, MID Labs, Scieran) |
| Viscous Fluid Injection Viscosities | 1000 or 5000 cs | 1000 or 5000 cs | 1000 or 5000 cs (Alcon) |
| Viscous Fluid Extraction | Present (if predicate has it) | YES | NO (for Storz, MID Labs, Scieran) |
| Multifunction Footswitch | Present | YES | YES |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a comparison of device specifications to predicate devices, not a study involving patient data or a "test set" in the context of diagnostic accuracy. The provenance of the data is the device's own specifications and publicly available information about predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No "ground truth" derived from expert assessment of a test set is mentioned or required for this type of submission. The "ground truth" is the demonstrated functionality and specifications of the device itself and its predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication process is described for a test set.
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
- Not Applicable. This is not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the functional specifications and intended use of the D.O.R.C. Harmony Total Vitrectomy System and its predicate devices. Substantial equivalence is established by demonstrating that these characteristics are similar enough to ensure equivalent safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is a hardware surgical system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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
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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.
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| D.O.R.C. HarmonyTotal | Alcon SurgicalAccurus | Storz Millenium | MID LabsSupraVit/VitMateVitreoretinalSystem | ScieranTechnologiesVit Commander | |
|---|---|---|---|---|---|
| 510(k) number | current submission | unknown | K961310 | K932669/K24222 | K961738 |
| Intended Use | Posterior segmentophthalmic surgery | Posterior segmentophthalmic surgery | Posterior segmentophthalmic surgery | Posterior segmentophthalmic surgery | Posterior segmentophthalmic surgery |
| Features/Specifications | |||||
| Computer Based System | NO | YES | YES | unknown | unknown |
| Vitrectomy | YES | YES | YES | YES | YES |
| type: | guillotine cutter | guillotine or radialreciprocating cutter | guillotine cutter | guillotine cutter | guillotine cutter |
| drive mechanism: | pneumatic or electric | pneumatic800 or 1200cuts/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 |
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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
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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_
§ 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.