(34 days)
Not Found
No
The summary describes standard, reusable endoscopic instruments without any mention of AI/ML capabilities or related data/performance metrics.
No
The device is described as surgical instruments (graspers, dissectors, scissors) used for manipulating, cutting, and cauterizing tissue during endoscopic/laparoscopic procedures, which are interventional rather than therapeutic in nature. therapeutic devices are usually directly involved in treating diseases or conditions.
No
Explanation: The device is described as surgical instruments (graspers, dissectors, scissors) used to perform actions like grasping, manipulating, cutting, and cauterizing soft tissue in endoscopic/laparoscopic procedures. These are interventional/surgical functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states that the Interceptre™ Endoscopic instruments are "hand-held, non-sterile, reusable instruments," indicating they are physical hardware devices.
Based on the provided information, the Interceptre™ Endoscopic Instruments are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "endoscopic/laparoscopic procedures" to "grasp, manipulate, cut, cauterize soft tissue." This describes a surgical instrument used in vivo (within the body) for direct manipulation of tissue.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health.
- Device Description: The description confirms they are "hand-held, non-sterile, reusable instruments" used for surgical procedures.
The information provided clearly indicates the device is a surgical instrument for use during procedures, not a device for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Interceptre™ Endoscopic Instrumentation is intended to be used for the management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue.
The Interceptre™ Endoscopic Instrumentation is indicated for use in endoscopic procedures.
The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.
Product codes
GCJ, HET, BWA, KNS
Device Description
The Interceptre™ Endoscopic instruments are a line of hand-held , non-sterile, reusable instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
K974592, Karl Storz Take-Apart Endoscopic Instruments, Richard Wolf Laparoscopic Instruments
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 5- 510k Summary of Safety and Effectiveness
16974892
This summary of 510k safety and effectiveness information is being submitted in 5.1 accordance with the requirements of SMDA 1990 and CFR 807.92 Statement
Smith and Nephew, Inc. 5.2 Submitter 130 Forbes Boulevard Mansfield, Ma. 02048 、 ·
5.3 Susan Finneran Company Clinical/ Regulatory Affairs Contact (508) 261-3772
Proprietary Name: Interceptre™ Laparoscopic Instruments 5.4 Common Name: Minimally Invasive Surgical Instruments: graspers, dissectors, Device Name scissors, Classification Name: Endoscopic accessories(78 GCJ) Laparoscopic accessories (85 HET) Electrosurgical accessories (79 BWA, 78 KNS)
| 5.5
Predicate
Legally
Marketed
Devices | • Karl Storz Take-Apart Endoscopic Instruments
• Richard Wolf Laparoscopic Instruments |
| ---------------------------------------------------- | ------------------------------------------------------------------------------------------- |
|---|
006
1
The Interceptre™ Endoscopic instruments are a line of hand-held , non-sterile, ર્ડ.6 Device reusable instruments Description
The Interceptre™ Endoscopic Instrumentation is intended to be used for the 5.7 management of soft tissue. The instruments are intended to be used to grasp, Intended Use dissect, and cut soft tissue.
ﺷﻌﺒﻪ ﺍ
The Interceptre™ Endoscopic Instrumentation is indicated for use in endoscopic 5.8 Device Indications procedures. で
The Interceptre™ Endoscopic Instrumentation is substantially equivalent to the રું. જેન્ડો જિલ્લાનું મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશ Karl Storz Take-Apart Endoscopic Instruments and the Richard Wolf Laparoscopic Substantial Equivalence Instruments. The table below summarizes the similarities of the three product lines. The similarities between the Interceptre™ Endoscopic Instrumentation and the instruments in the other two product lines support the claim of substantial equivalence.
2
TABLE OF SUBSTANTIAL EQUIVALENCE
| Product Name | Interceptre MIS II Endoscopic Instruments | Karl Storz Take-Apart Endoscopic Instruments | Richard Wolf Laparoscopic Instruments | Smith Nephew Endoscopic Instruments |
|---|---|---|---|---|
| Product Labeling | non-sterile/reusable | non-sterile/reusable | non-sterile/reusable | non-sterile reusable |
| Materials | Stainless steel/Kynar insulation | Stainless steel/ insulation | Stainless steel/ plastic/insulation | Stainless Steel/Kynar insulation |
| Indications | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures |
| Intended Use | Management of Soft Tissue | Management of Soft Tissue | Management of Soft Tissue | Management of Soft Tissue |
| Tip Styles | graspers, dissectors, scissors | graspers, dissectors, scissors | graspers, dissectors, scissors | graspers, scissors, dissectors |
| Number of separate components | 3 | 3 | 3 | 1 |
| Design | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design |
Applicant Sus Penn
Date 12/8/97
008
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Susan A. Finneran Clinical/Regulatory Affairs Smith & Nephew, Incorporated Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K974592
Trade Name: Interceptre Laparoscopic Instruments Regulatory Class: II Product Code: GCJ Dated: December 8, 1997 Received: December 9, 1997
Dear Ms. Finneran:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Finneran
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510 (k) Number (If Known):
Lap aroscopic Device Name: Interceptre™ Endoscopic Instruments
Indications For Use:
The Interceptre™ Endoscopic Instruments are indicated for use in endoscopic/laparoscopic procedures
Intended Use:
The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) or Over-The-Counter Use __
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974592
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