(55 days)
The Statarius™ is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
The Statarius™ is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The Statarius™ eliminates the need for the surgeon or assistant to continuously hold an endoscope during surgical procedures.
The provided document is a 510(k) summary for the Statarius™ Endoscope Holder, which is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum and is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Armand Endoscope Holder, K5050051).
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Attachment B2
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Statarius™M Endoscope Holder Summary
JUL - 3 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All information included in this document is accurate and complete to the best of KSLLC's knowledge.
| Applicant: | Kinetic Surgical LLC2157 Vista La NisaCarlsbad, CA 92009 |
|---|---|
| Contact Person: | Jim CaputoPresident |
| Date of Summary: | 05/05/06 |
| Device Name: | Statarius TM |
| Common Name: | Endoscope Holder |
| Regulatory Class: | Class II |
| Predicate Device: | Armand Endoscope Holder(K5050051) |
| Intended Use: | The Statarius TM is intended for use by surgeons for holdingrigid and flexible endoscopes with diameters from 5-12mmduring diagnostic and therapeutic surgical procedures. |
| Device Description: | The Statarius TM is a manually operated, mechanicalsurgical device. It is primarily composed of stainless steeland anodized aluminum. The instrument provides for theone handed control for the positioning/repositioning of anendoscope during surgical procedures. The Statarius TMeliminates the need for the surgeon or assistant tocontinuously hold an endoscope during surgicalprocedures. |
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Attachment B2
61292
Substantial Equivalence:
The Statarius™ is substantially equivalent in application
and function to the Armand Endoscope Holder.
page 2 of 2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JOE - 3 2006
Kinetic Surgical, LLC c/o Mr. Jim Caputo President 2157 Vista La Nisa Carlsbad, California 92009
Re: K061292
Trade/Device Name: Statarius™ Endoscope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 20, 2006 Received: June 23, 2006
Dear Mr. Caputo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jim Caputo
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation on t), pd, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may notain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Helentemerson
/ Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment Bl
Kob 1292
Indications for Use
510(k) Number: K061292
Device Name: Statarius™ Endoscope Holder
Indications For Use:
The Statarius™ is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
Prescription Use X (Per 21 CFR 801Subpart D)
AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Reemer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061292
4 - 1
§ 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.