(203 days)
The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
The Marionette™ SA is a manually operated, articulating mechanical surgical device. It is primarily composed of stainless steel, anodized aluminum and Delrin. The instrument provides for the one handed control (left or right hand) of the positioning/repositioning of an instrument that includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components.
The provided 510(k) summary for the Marionette™ SA (K072811) does not contain details about acceptance criteria, device performance, or human subject studies with ground truth data.
This document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. For devices like the Marionette™ SA, which are manual surgical instruments (graspers, scissors, dissectors), the regulatory submission often relies on a comparison of design, materials, manufacturing processes, and intended use to existing legally marketed devices. Performance testing typically involves bench testing, biocompatibility, and sterilization validation, rather than clinical efficacy studies with specific acceptance criteria that would generate the kind of data requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.
Here's what I can extract from the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. It's highly probable that any performance testing conducted would have been bench testing or internal validation, rather than clinical studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no human subject study with ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no human subject study with ground truth establishment is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was mentioned. This device is a manual surgical instrument, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no human subject study with ground truth establishment is described.
8. The sample size for the training set
- Not applicable as no machine learning or AI component is described.
9. How the ground truth for the training set was established
- Not applicable as no machine learning or AI component is described.
Summary of what the document does provide:
- Intended Use: The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
- Device Description: A manually operated, articulating mechanical surgical device primarily composed of stainless steel, anodized aluminum, and Delrin. It provides one-handed control and the ability to change disposable/reusable tips.
- Substantial Equivalence: The device claims substantial equivalence in application and function to the Endolink True Movement System (K043541), Cambridge Laparo-Angle (K061425), and Microline Re-New laparoscopic instrument (K962119). This is the primary basis for its clearance, implying that its performance characteristics are considered comparable to these predicate devices based on design and intended use, not necessarily through clinical trials directly comparing performance metrics.
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K072811 - P. 1 of 7
APR 2 1 2008
Marionette™ SA (Surgical Assistant) Summary
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 LLC6215 Ferris Square, Ste. 100San Diego, CA 92121 |
|---|---|
| Contact Person: | Jim CaputoPresident |
| Date of Summary: | April 15, 2008 |
| Device Name: | Marionette™ SA |
| Common Name: | Grasper, Scissors, & Dissector |
| Regulatory Class: | Class II |
| Predicate Device: | Endolink True Movement system(K043541)Microline Incorporated Re-New Laparoscopic Instruments(K962119)Cambridge Laparo-Angle(K061425) |
| Intended Use: | The Marionette™ SA is intended for use by surgeons forgrasping, dissection, and tissue cutting during laparoscopicsurgical procedures. |
| Device Description: | The Marionette™ SA is a manually operated, articulatingmechanical surgical device. It is primarily composed ofstainless steel, anodized aluminum and Delrin. Theinstrument provides for the one handed control (left or righthand) of the positioning/repositioning of an instrument that |
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f072811 p. 2c 2
includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components.
Substantial Equivalence:
The Marionette™ SA is substantially equivalent in application and function to the Endolink True Movement System, Cambridge Laparo-Angle and the Microline Re-New laparoscopic instrument.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kinetic Surgical, LLC % Mr. Jim Caputo 6215 Ferris Square, Suite 100
APR 2 1 2008
Re: K072811
San Diego, California 92121
President
Trade/Device Name: Marionette™ SA (Surgical Assistant) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 7, 2008 Received: April 9, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mullan
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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Indications For Use
APPENDIX D
510(k) number: K072811
Device Name: Marionette™ SA (Surgical Assistant)
The Marionette™ SA is intended for use by surgeons for grasping, dissection, tissue cutting during laparoscopic surgical procedures.
Prescription Use (Per 21 CFR 801 Subpart D)
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, O exice Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072811
§ 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.