(235 days)
This device is a protective finger guard accessory to the surgeon's glove. (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. (b) Facilitate suture handling and placement.
This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.
The provided 510(k) summary for the MARINA MEDICAL FINGER PROTECTOR (K042534) does not describe a clinical study or performance tests with specific acceptance criteria and reported device performance in the way a typical diagnostic device submission would. Instead, this submission relies on demonstrating substantial equivalence to a predicate device (DIGICAP, K012199) primarily through comparison of technological characteristics.
Therefore, the acceptance criteria and study information will be presented reflecting this approach.
Acceptance Criteria and Study Proving Device Meets Criteria
The Marina Medical Finger Protector (K042534) sought clearance by demonstrating substantial equivalence to a predicate device (DIGICAP, K012199). The "acceptance criteria" in this context are the demonstrated identical technological characteristics to the predicate device, which inherently implies identical performance, safety, and effectiveness. The "study" proving this largely involves a comparative analysis against the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate K012199) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Indications for use are identical | Identical |
| Target population is identical | Identical |
| Design is identical | Identical |
| Materials are identical | Identical |
| Performance is identical | Identical |
| Sterility is identical | Identical |
| Biocompatibility is identical | Identical |
| Mechanical safety is identical | Identical |
| Chemical safety is identical | Identical |
| Anatomical sites are identical | Identical |
| Human factors are identical | Identical |
| Compatibility with environment and other devices is identical | Identical |
| Where used is identical | Identical |
| Standards met are identical | Identical |
Note: "Energy used and/or delivered", "Electrical safety", "Thermal safety", and "Radiation safety" were deemed "Not applicable" for this device and thus were not criteria for comparison.
2. Sample size used for the test set and the data provenance
There was no "test set" in the traditional sense of clinical data or performance measurements on a specific sample size of the device. The comparison was based on the technological characteristics and established performance of the legally marketed predicate device (DIGICAP, K012199). Data provenance for such comparison would be the established regulatory clearances and documentation of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth was not established by experts for a specific test set, as no clinical or performance study with a test set was conducted for this submission. The ground truth for device safety and effectiveness was established through the prior clearance of the predicate device and the comprehensive comparison of characteristics.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.
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 device is a sterile single-use protective finger guard, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the clearance of the Marina Medical Finger Protector was the demonstrated substantial equivalence to a predicate device (DIGICAP, K012199) that had already been deemed safe and effective. The premise is that if the new device is technologically identical to a legally marketed device, it shares the same safety and effectiveness profile.
8. The sample size for the training set
Not applicable. No training set was used for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used or required.
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510(k) Summary MAY 1 0 2005 As Required by 21 section 807.92 ( c )
1-Submitter Name: Marina Medical
| 2-Address: | 2761 N. 29th AvenueHollywood, FL 33020 |
|---|---|
| ------------ | -------------------------------------------- |
| 3-Phone: | (954) 924-4418 |
|---|---|
| 4-Fax: | (954) 924-4419 |
| 5-Contact Person: | Anthony Zinnanti |
6-Date summary prepared: March 23th, 2005 by Jay Mansour-Mansour Consulting LLC
7-Device Trade or Proprietary Name: MARINA MEDICAL FINGER PROTECTOR
- 8-Device Common or usual name: SURGEON'S FINGER PROTECTOR
- 9-Device Classification Name: NEEDLE ACCESSORY
- 10-Substantial Equivalency is claimed against the following device: DIGICAP, cleared via K012199 for HUMANA USA, INC
11-Description of the Device:
This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.
12-Intended use of the device:
This device is a protective finger guard accessory to the surgeon's glove.
- (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures.
- (b) Facilitate suture handling and placement.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
SUMMARY - PAGE 7-REVISED
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| FDA file reference number | 510k # K012199 |
|---|---|
| TECHNOLOGICALCHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Not applicable |
| Compatibility with environmentand other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Not applicable |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
PAGE 8- REUISED
--------------------------------------------------------------------------------------------------------------------------------------------------------------- Sunnary -
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
MAY 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marina Medical Instruments, Incorporated C/O Mr. Jay Mansour President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, California 30022
Re: K042534
Trade/Device Name: Marina Medical Finger Protector Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 27, 2005 Received: April 28, 2005
Dear Mr. Mansour:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becally becally be is substantially equivalent (for the referenced above and have determined the accosure) to legally marketed predicated in indications for use stated in allo encreating , the enactment date of the Medical Device interstate colliments, or to triay 20, 1978, essified in accordance with the provisions of Amendinents, of to devices that have oost (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment 1900 (1997) - market the device, subject to the general approval application (1 Mrx). Four general controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for aisitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Colors your device can be found in the Code of Peacharting your device in the Federal Register.
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Page 2 -Ms. Mansour
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I Dri b issuained on that your device complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regarments, including, but not limited to: registration You must comply with an the Hotel Jog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Purt 067), labeling (21 CFR Part 820); and if requirents as set form in the quality sign 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) This letter will anow you to oegal mading of substantial equivalence of your device to a premiarket notification. "The PDF mixts 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), If you desire specific advice for your as not on a comments of the regulation please contact the Other or Ochiphen to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general misteriational 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/industry/support/index.html.
Sincerely vours,
Sayre H. Michie, MD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042534
Device Name: MARINA MEDICAL FINGER PROTECTOR
Indications For Use:
This device is a protective finger guard accessory to the surgeon's glove.
(a) intended to provide needlestick and suture/scalpel protection during a variety of surgical (a) intended to provide necalestion and ectarers and cressory to the surgeon's glove. It is used on the procedures. It is a procouve iniger gaan usually used to retract, stabilize, compress, and position tissue during surgical procedures.
(b) Facilitate suture handling and placement.
S Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shady K. Murphy, R
. Liston of Anesthosiblogy, General Hospital, Intection Control, Dental Devices
Page 1 of 1
3(k) Number: K042534
PAGE 11 - REVISED
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).