(12 days)
Not Found
No
The description focuses on mechanical functions and interchangeable parts, with no mention of AI/ML terms or capabilities.
No
The device is described as an endoscopic surgical instrument used for cutting, grasping, dissecting, retracting, and manipulating functions during procedures, which are interventional actions rather than therapeutic ones. It does not provide any treatment or therapy itself.
No
The device description states it is for "cutting, grasping, dissecting, retracting, and manipulating functions" during endoscopic surgical procedures. These are therapeutic and interventional functions, not diagnostic ones.
No
The device description clearly describes physical, reusable endoscopic instruments with handles, jaws, and shafts, indicating it is a hardware device, not software only.
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 use in endoscopic surgical procedures to perform actions like cutting, grasping, dissecting, retracting, and manipulating. These are actions performed on the patient's body during surgery.
- Device Description: The description details a surgical instrument with jaws and a handle designed for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
Product codes (comma separated list FDA assigned to the subject device)
78 KOG
Device Description
The K&W 2-Piece Take-Apart Instrumentation are endoscopic instruments which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the iaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.
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.
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
Image /page/0/Picture/0 description: The image shows a logo with the letters 'KW' in a stylized design. The 'K' is formed by a vertical line intersected by a horizontal line, with an angled line connecting to the 'W'. The 'W' is depicted in a bold, zig-zag shape. A registered trademark symbol is present near the bottom right of the 'W'.
SEP 1 0 1997
973259 Page 1 of 3
510(k) Summary
Submitter's Name, Address and Telephone Number, and Contact Person: 1.
Perk Crook Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar, PA 18915
Telephone: (215) 997-9689
Contact Person: Perk Crook
2. Name of the Device, including the trade or proprietary name if applicable, and the common name, and the classification name, if known:
Trade Name: K&W 2-Piece Take-Apart Instruments
Endoscopic Forceps/Graspers/Scissors Common Name:
Classification Name: Endoscopic and Accessories
3. Identification of the legally marketed device that the submitter claims equivalence:
The devices in consideration are substantially equivalent to the devices currently marketed by Karl Storz Endoscopy America, Inc., under 510(k) K952149.
1
Image /page/1/Picture/0 description: The image shows a handwritten number sequence "K973259" at the top. Below the number sequence, the text "Page 2 of 3" is printed. The text indicates that this is the second page of a three-page document. The handwriting appears to be in black ink.
A description of the device that is the subject of the premarket notification 4. submission, such as might be found in the labeling or the promotional material of the device:
The K&W 2-Piece Take-Apart Instrumentation are endoscopic instruments which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the iaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.
A statement of the intended use of the device that is the subject of the 5. premarket notification:
The K&W 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
- lf the device has the same technological characteristics as the predicate 6. device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of new device in comparision to those of the predicate device; if the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to the legally marketed device:
The intended uses of the K&W 2-Piece Take-Apart Instrumentation and the Karl Storz Endoscopy America, Inc. Devices under K952149 have the same intended use, and that is for endoscov proceures through cannulae for cutting, grasping, dissecting, retracting, and manipulating.
The devices have reusable handles that accommodate inserts, that can be rotated 360 degrees during use.
Both devices include insulated and noninsulated handles, and accommodating shafts.
In the K&W device there is included flushing port to facilitate cleaning. This port
2
Image /page/2/Picture/0 description: The image shows a handwritten number sequence "K973259" at the top. Below the number sequence, the text "Page 3 of 3" is printed. The text indicates that this is the last page of a document.
is not present on the Karl Storz devices.
All K&W device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral port of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button. In some of the Storz instruments, security is achieved by a one-quarter turn into the outer tube and then connecting into the outer tube handle. The rest of the Storz instruments are the same as K&W.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1997
Ms. Perk Crook Official Correspondent Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar, Pennsylvania 18915-9727
Re: K973259 K&W Two-Piece Take-Apart Instrumentation Dated: August 26, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG
Dear Ms. Crook:
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 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 misbranion.
If your device is classified (see above) into either 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 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 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,
h.7liau Yu
Lillian Yin, Ph.D.
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
4
Page_ 1_of_1__
510(k) Number (if known): _
Device Name: 2-Piece Take-Apart Instruments
Indications For Use:
(Per 21 CFR 801.109)
For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Rober 7 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number . Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_v
(Optional Format 1-2-96)