(51 days)
No
The 510(k) summary describes a mechanical stapling device and does not mention any AI or ML components or functionalities.
Yes
The device is described as an endoscopic stapling device intended for use in affixing prosthetic material or approximating tissue, which are therapeutic actions.
No
The device description states it is an "endoscopic stapling device" intended for "affixing prosthetic material or approximating tissue." Its function is interventional (stapling tissue), not diagnostic.
No
The device description explicitly states it is an "endoscopic stapling device" and is "disposable and is supplied sterile," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in affixing prosthetic material or approximating tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "endoscopic stapling device." This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is used to perform a surgical action directly on the body.
N/A
Intended Use / Indications for Use
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.
Product codes
Not Found
Device Description
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is an endoscopic stapling device. The device is disposable and is supplied sterile.
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)
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device was tested both in-vivo and in-vitro to evaluate fastener security. The results of this testing demonstrate that the subject device provides adequate fastener strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Origin® Tacker™ System (K944415)
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
K96399
United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Modified Endoscopic Fascia Stapler**
510(K) SUMMARY OF INFORMATION SUPPORTING SAFETY AND SUMMARY EFFECTIVENESS
SUBMITTER: United States Surgical Corporation NOV 27 1996 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
CONTACT PERSON: Christopher Taylor
October 4. 1996 DATE PREPARED:
CLASSIFICATION NAME: Implantable Staple
ﭘ
COMMON NAME: Surgical Staple
PROPRIETARY NAME: Trademark name not vet determined.
PREDICATE DEVICE: Origin® Tacker™ System (K944415)
The AUTO SUTURE* Modified Endoscopic Fascia DEVICE DESCRIPTION: Stapler** device is an endoscopic stapling device. The device is disposable and is supplied sterile.
INTENDED USE:
... ... ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MATERIALS:
All component materials of the AUTO SUTURE* Modified Endoscopic Fascia Stapler** device are comprised of materials which are in accordance with ISO Standard #10993-1.
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic
used both endoscopically and in open procedures.
material or approximating tissue. This device may be
The AUTO SUTURE* Modified Endoscopic Fascia PERFORMANCE: Stapler** device was tested both in-vivo and in-vitro to evaluate fastener security. The results of this testing demonstrate that the subject device provides adequate fastener strength.
- Trademark of United States Surgical Corporation ** Trademark name not yet determined