(87 days)
Olympus FG – 4/14/20/21/22/26/32/38/40/##-1
Not Found
No
The summary describes a purely mechanical grasping device with no mention of AI, ML, or any computational analysis of the endoscopic visualization.
No
The device is described as grasping forceps intended to grasp tissue and/or retrieve foreign bodies, excised tissue, and stents. This is an assistive tool for procedures, not a device directly providing therapy.
No
Explanation: The device is described as grasping forceps used to retrieve tissue or foreign bodies. Its function is interventional (grasping/retrieving) rather than diagnostic (identifying or characterizing a condition).
No
The device description clearly outlines physical components like a flexible shaft, proximal control handle, and distal tip grasping jaws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states the device is used to "grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract." This is a surgical or interventional tool used inside the body during an endoscopic procedure.
- Lack of Diagnostic Testing: There is no mention of the device being used to perform any kind of test on a sample to diagnose a condition or provide health information. Its function is purely mechanical for manipulation and retrieval within the body.
Therefore, the function and intended use of this grasping forceps align with a surgical or interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Grasping forceps are intended to be used to grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract. .
Product codes (comma separated list FDA assigned to the subject device)
OCZ
Device Description
The EndoChoice grasping forceps are designed for grasping tissue and / or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
No performance standards exist for this device.
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.
Olympus FG – 4/14/20/21/22/26/32/38/40/##-1
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K 101298
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name and
Address: | EndoChoice, Inc.
11800 Wills Rd, Suite 100
Alpharetta, GA 30009
AUG - 5 2010 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theron Gober
Quality and Regulatory Manager |
| Phone Number: | 678-534-6021 |
| Fax Number: | 770-410-9008 |
| Establishment
Registration Number: | 300759133 |
| Date Prepared: | April 16, 2010 |
| Device Trade Name(s): | EndoChoice Grasping Forceps: |
| Device Common Name: | Grasping forceps |
| Classification Name: | KOG - Endoscope and accessories |
| Predicate Device(s): | Olympus FG – 4/14/20/21/22/26/32/38/40/##-1 |
| General Device
Description: | The EndoChoice grasping forceps are designed for grasping
tissue and / or retrieving foreign body, and excised tissue
under endoscopic visualization. These forceps consist of a
flexible shaft and a proximal control handle. Operation of the
proximal control handle actuates the distal tip grasping jaws. |
| Intended Use: | Grasping forceps are intended to be used to grasp tissue and
/ or retrieve foreign bodies, excised tissue, and stents from
within the gastrointestinal tract. |
| Technological
Characteristics: | From a clinical perspective and comparing design
specifications, the EndoChoice grasping forceps and the
predicate device are substantially equivalent. Based on the
technological characteristics and overall performance of the
devices, EndoChoice, Inc. believes that no significant
differences exist between the proposed grasping forceps and
the predicate devices. |
Description
1
K 101298
pg 2 of 2
EndoChoice, Inc. believes the minor differences of the grasping forceps and its predicates device should not raise any concerns regarding the overall safety or effectiveness.
Performance Data:
No performance standards exist for this device.
Conclusion:
Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the grasping forceps and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Theron Gober Quality and Regulatory Manager EndoChoice, Inc. 11800 Wills Road, Suite 100 ALPHARETTA GA 30009-2089
Re: K101298
Trade/Device Name: EndoChoice Grasping Forceps Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: OCZ Dated: May 7, 2010 Received: May 11, 2010
000 - 5 - 2010
Dear Mr.Gober:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
3
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Huker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K101298
AUG - 5 2010
Device Name: Grasping Forceps
Indications for Use
Grasping forceps are intended to be used to grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use_ · (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number