(235 days)
Not Found
No
The device description and intended use clearly describe a physical protective finger guard, with no mention of software, data processing, or AI/ML terms.
No.
The device is described as a "protective finger guard" intended to provide "needlestick and suture/scalpel protection" and to "facilitate suture handling and placement." It does not directly treat or diagnose a disease or condition, nor does it restore, correct, or modify a bodily function or structure. Its primary role is protective and accessory to a surgical procedure.
No
This device is described as a "protective finger guard accessory" used during surgical procedures to provide protection and facilitate suture handling. Its intended use is mechanical protection and assistance, not to diagnose a condition or disease.
No
The device description explicitly states it is a "sterile single use protective finger guard worn in conjunction with surgeon's glove," indicating it is a physical accessory, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a physical barrier worn on the finger during surgery. Its purpose is to protect the surgeon from injury and facilitate handling of surgical materials. It does not analyze any biological specimens or provide diagnostic information.
The description clearly indicates it's a protective accessory for surgical procedures, not a diagnostic tool.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or thumb of the non-dominant hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
§ 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).
0
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 Avenue
Hollywood, 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
1
| FDA file reference number | 510k # K012199 |
|---|---|
| TECHNOLOGICAL | |
| CHARACTERISTICS | 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 environment | |
| and 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 -
2
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.
3
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
4
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