(55 days)
K5050051
K5050051
No
The device description explicitly states it is a "manually operated, mechanical surgical device" and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is described as a manually operated, mechanical surgical device intended for holding endoscopes, not for directly treating a disease or condition. It is an accessory used during surgical procedures.
No
The device is described as an endoscope holder for use during diagnostic and therapeutic surgical procedures. Its function is to hold an endoscope, not to perform a diagnostic function itself. The diagnostic aspect is related to the procedures it facilitates, not the device's inherent capability.
No
The device description explicitly states it is a "manually operated, mechanical surgical device" primarily composed of "stainless steel and anodized aluminum," indicating it is a physical hardware device.
Based on the provided information, the Statarius™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Statarius™ is for holding endoscopes during surgical procedures. This is a mechanical function performed on the patient during a medical intervention.
- Device Description: The description confirms it's a "manually operated, mechanical surgical device" used for positioning/repositioning an endoscope.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The Statarius™ does not interact with patient specimens in this way.
Therefore, the Statarius™ is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Statarius TM is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
Product codes
GCJ
Device Description
The Statarius TM 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 TM eliminates the need for the surgeon or assistant to continuously hold an endoscope during surgical procedures.
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
surgeons
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)
Armand Endoscope Holder (K5050051)
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
Attachment B2
Image /page/0/Picture/1 description: The image shows the logo for Kinetic Surgical LLC. The logo features a stylized letter K with arrows indicating movement. The text "Kinetic Surgical LLC" is written in a bold, slightly italicized font to the right of the letter K.
106 1292
page 1 of 2
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 LLC
2157 Vista La Nisa
Carlsbad, CA 92009 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Caputo
President |
| 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 holding
rigid and flexible endoscopes with diameters from 5-12mm
during diagnostic and therapeutic surgical procedures. |
| Device Description: | The Statarius TM 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 TM
eliminates the need for the surgeon or assistant to
continuously hold an endoscope during surgical
procedures. |
1
Attachment B2
61292
Substantial Equivalence:
The Statarius™ is substantially equivalent in application
and function to the Armand Endoscope Holder.
page 2 of 2
2
Image /page/2/Picture/1 description: The image shows a stylized logo. The logo features three curved lines that resemble a bird in flight, positioned within a partial circle. The lines are thick and black, creating a sense of movement and dynamism. The partial circle is made up of small dots.
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.
3
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
4
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