(40 days)
Not Found
No
The summary describes standard surgical instruments and makes no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device description states it is a line of hand-held instruments for grasping, dissecting, and cutting soft tissue in surgical procedures. It does not claim to treat, cure, mitigate, or prevent disease, nor does it affect the structure or any function of the body in a therapeutic manner.
No
The device description indicates that the instruments are used to "grasp, dissect, and cut soft tissue" during surgical procedures. There is no mention of the device being used to identify or analyze conditions or diseases, which would characterize a diagnostic device.
No
The device description explicitly states it is a line of hand-held, non-sterile, reusable instruments, indicating it is a hardware device.
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 instruments are for the "surgical management of soft tissue" and are used to "grasp, dissect, and cut soft tissue" during "endoscopic procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description confirms they are "hand-held, non-sterile, reusable instruments," which aligns with surgical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical instrument used during a procedure on the patient.
N/A
Intended Use / Indications for Use
The Smith & Nephew MIS Instruments are intended to be used in the surgical management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue. The Smith & Nephew MIS Instruments are indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures.
Product codes
78 GCJ, 85 HET, 79 BWA, 78 KNS
Device Description
The Smith & Nephew MIS 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
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Section 8- 510k Summary of Safety and Effectiveness
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
. . . . . .
K 970949
| 8.1
Statement | This summary of 510k safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8.2
Submitter | Smith and Nephew Endoscopy, Inc.
Endoscopy Division
130 Forbes Boulevard
Mansfield, Ma. 02048 |
| 8.3
Company
Contact | Amy Walters
Clinical/ Regulatory Manager
(508) 261-3774 |
| 8.4
Device
Name | Proprietary Name: Smith & Nephew MIS Instruments
Common Name: Minimally Invasive Surgical Instruments: graspers, dissectors, scissors.
Classification Name: Endoscopic accessories (78 GCJ)
Laparoscopic accessories (85 HET)
Electrosurgical accessories (79 BWA, 78 KNS) |
| 8.5
Predicate
Legally
Marketed
Devices | Karl Storz Take-Apart Endoscopic Instruments Richard Wolf Laparoscopic Instruments Smith & Nephew and Acufex MIS Instruments |
| 8.6
Device
Description | The Smith & Nephew MIS Instruments are a line of hand-held, non-sterile, reusable instruments. |
| 8.7
Intended Use | The Smith & Nephew MIS Instruments are intended to be used in the surgical management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue. |
1
The Smith & Nephew MIS Instruments are indicated for use in endoscopic 8.8 Device procedures, including thoracoscopic surgery and laparoscopic procedures. Indications
The Smith & Nephew MIS Instruments are substantially equivalent to the Karl 8.9 Storz Take-Apart Endoscopic Instruments and the Richard Wolf Laparoscopic Substantial Equivalence Instruments.
The table below summarizes the similarties of the three product lines. The similarities in design, materials, intended use, and indications for use between the Smith & Nephew MIS Instruments and the predicate devices support the claim of substantial equivalence.
2
| | Smith &
Nephew MIS
Instruments | Karl Storz Take-Apart
Endoscopic Instruments | Richard Wolf
Laparoscopic
Instruments | Smith
Nephew &
Acufex
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 | Management | Management of Soft
Tissue | Management of
Soft Tissue | Management
of Soft Tissue |
| Use
Tip Styles | of Soft Tissue
graspers,
dissectors,
scissors | graspers, dissectors,
scissors | graspers,
dissectors,
scissors | graspers,
scissors,
dissectors |
| Number of
separate | 3 | 3 | 3 | 1 |
| components
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 Amy L. Watkins
Date 3/1/97
097
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