(42 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for a reusable biopsy instrument, which is typically a mechanical device.
No
The device is described as a biopsy instrument, which is used for diagnostic purposes (collecting tissue samples) rather than directly treating a condition.
Yes
The device is described as a "Biopsy Instrument," and the intended use is stated as collecting biopsies, which are samples of tissue or cells for diagnostic purposes.
No
The device description explicitly states it is a "reusable biopsy instrument," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states it's a "Biopsy Instrument" used for taking biopsies. Biopsies are samples of tissue taken from the body, not tests performed in vitro (outside the body) on bodily fluids or substances.
- Device Description: It's described as a "reusable biopsy instrument," which aligns with a surgical or procedural tool used to obtain a sample, not a diagnostic test kit or analyzer.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing bodily fluids (blood, urine, etc.)
- Detecting specific analytes (proteins, genes, etc.)
- Providing diagnostic information based on laboratory analysis.
The device's function is to obtain a sample, which is then typically sent to a laboratory for in vitro diagnostic testing. The instrument itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
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
United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Biopsy Instrument** device
APR - 5 1996
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
The AUTO SUTURE* Biopsy Instrument** device is identical in safety and effectiveness to its currently marketed predicate - IMAGYN Medical Inc's biopsy instrument as described in Laparoscopic Instruments - 510(k) #K944129. United States Surgical Corporation has been manufacturing endoscopic hand instruments as accessories in surgical procedures for a number of years. It is now the intention of USSC to manufacture for the marketplace a reusable biopsy instruments identical to that described in IMAGYN's 510(k). The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization.
- Both the subject and predicate devices are designed and indicated for the same procedures. ●
- . Both the subject device and other currently marketed United States Surgical Corporation devices are manufactured in the same facilities, using similar processes and controls.
- . Both the subject device and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- Both the subject and predicate devices perform the exact same function in the same way. .