(144 days)
Endo-bend™ Grasper, Precisor Disposable Forceps and Graspers Reusable Graspers, AMD™ System
Not Found
No
The device description and intended use clearly describe a manual surgical instrument with mechanical articulation, with no mention of AI or ML capabilities.
No.
The device is described as a "manual instrument intended for use in tissue grasping, dissecting and cutting" during surgical procedures, which are interventional actions, not therapeutic ones in themselves.
No
The device is described as a "manual instrument intended for use in tissue grasping, dissecting and cutting," which are therapeutic or surgical functions, not diagnostic ones.
No
The device description clearly outlines multiple physical components (tissue engaging tip, vertebra joints, shaft, radius control sheath, pistol grip handle) which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery." This describes a surgical instrument used in vivo (within the body) during a procedure.
- Device Description: The description details a mechanical instrument with a tip, joints, shaft, sheath, and handle. This aligns with the description of a surgical tool, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue samples, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on tissue during a procedure.
N/A
Intended Use / Indications for Use
The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.
Product codes (comma separated list FDA assigned to the subject device)
77 EOB, 87 HRX
Device Description
The Endius Incorporated FlexTip™ Grasper is composed of:
- a tissue engaging tip of either a through cut or biting design
- a series of nested high density polycarbonate vertebra joints which allow articulation of the grasper tip
- a shaft section which connects the flexible end to the handle
- a radius control sheath used to control the radius of curvature of the flexible tip
- a pistol grip handle containing the control mechanism for the grasper tip.
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.
Endo-bend™ Grasper, Precisor Disposable Forceps and Graspers Reusable Graspers, AMD™ System
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) Summary FlexTip™ Grasper
SUBMITTER NAME AND ADDRESS 1.
NOV 2 1 1997
Endius Incorporated 23 West Bacon Street Plainville, MA 02762 Telephone: (508) 643-0983 (508) 695-2501 Telefax:
Thomas W. Davison, Ph.D. Contact:
DEVICE NAME 2.
| Proprietary Name: | FlexTip™ Grasper |
|---|---|
| Common/Usual Name: | Forceps |
| Classification Name: | Ear, nose and throat manual surgical instrument |
| manual arthroscopic instrument |
PREDICATE DEVICES 3.
- Endo-bend™ Grasper (Aust & Taylor Medical Corp.) .
- Precisor Disposable Forceps and Graspers Reusable Graspers (Smith & . Nephew Dyonics, Inc.)
- AMD™ System (Smith & Nephew Dyonics, Inc.). .
4. INTENDED USE
The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.
1
DEVICE DESCRIPTION ട.
The Endius Incorporated FlexTip™ Grasper is composed of:
- · a tissue engaging tip of either a through cut or biting design
- · a series of nested high density polycarbonate vertebra joints which allow articulation of the grasper tip
- a shaft section which connects the flexible end to the handle .
- · a radius control sheath used to control the radius of curvature of the flexible tip
- · a pistol grip handle containing the control mechanism for the grasper tip.
TECHNOLOGICAL CHARACTERISTICS 6.
The Endius Incorporated FlexTip™ Grasper and the substantially equivalent devices are all used for grasping, holding, manipulating or removal of tissue during surgical procedures. Tissue grasping is accomplished using a pivoting jaw configuration.
The Smith & Nephew Dyonics, Inc. devices all have rigid shafts with jaws either straight or at a specified angle. The proposed FlexTip™ Grasper and the Endobend™ Grasper have a flexible shaft due to the presence of a series of nested vertebrae joints, which allow adjustable shaft angulation. The Endo-bend™ Grasper can curve upward to 180°. The FlexTip™ Grasper can articulate 110° either above or below the plane of the shaft. A high density polyethylene radius control sheath slides over the stainless steel vertebrae to control the radius of curvature of the tip. The articulation feature of the FlexTip™ Grasper eliminates the need for numerous instruments with different tip angles.
The jaws of the Aust & Taylor Medical Corp. Endo-bend™ Grasper are of a biting forceps design. The proposed device and the Smith & Nephew Dyonics, Inc. disposable and reusable graspers and forceps have biting forcep and through cut jaw configurations in a variety of sizes.
The Smith & Nephew Dyonics, Inc. predicate devices use a scissor handle to open and close the jaws of the instrument. The Aust & Taylor device uses a trigger handle for jaw operation which is equivalent in design to that used in the proposed FlexTip™ Grasper.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of a bird-like figure, which is a common symbol associated with HHS.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynthia J. M. Nolte, Ph.D. Associate Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re:
K972450 FlexTip™ Grasper Dated: October 14, 1997 Received: October 15, 1997 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB 21 CFR 888.1100/Procode: 87 HRX NOV 2 1 1997
Dear Dr. Nolte:
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, 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 (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 requirement, as set forth in the Quality System Regulation (QS) 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 Radiation Control provisions, or other Federal laws or regulations.
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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.
W. Kiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K972450
Device Name: FlexTip™ Grasper
Indications For Use:
The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972450
Prescription Use _V (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)