(167 days)
The SPIDER™ (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.
The SPIDER is a pre-sterilized, single use, disposable, laparoscopic device. These devices are EO sterilized.
The provided text is a 510(k) summary for the TransEnterix SPIDER™ Standard and Advanced laparoscopic device. It details the device's intended use and a comparison to a predicate device, focusing on substantial equivalence. However, the document does not contain the specific information requested about acceptance criteria or a detailed study proving the device meets those criteria.
The document only generally states: "Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device."
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about any specific studies (sample size, data provenance, expert qualifications, etc.) as this information is not present in the provided text.
The document is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance study reports.
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102839 Page (1) of
510(k) Summary of Safety and Effectiveness
MAR 1 5 2011
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).
Submitter:
TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville, NC 27560
Contact: Bobbi L. Hadersbeck, MS Sr. RA and Compliance Specialist
Phone: (919) 765-8400 x 8554
(919) 765-8459 Fax:
Prepared: 09/27/2010
Common or Laparoscope, General and Plastic Surgery
Usual Name:
SPIDER™ Standard and SPIDER TM Advanced Proprietary Name:
Classification GCJ, Laparoscope, General and Plastic Surgery Name:
Manufactured TransEnterix, Inc. 635 Davis Drive Suite 300 By: Phone: (919) 765-8400 Fax: (919) 765-8459
Predicate Device(s): TransEnterix, Inc. K090902 SPIDER™ Standard and Advanced
Device Description: The SPIDER is a pre-sterilized, single use, disposable, laparoscopic device. These devices are EO sterilized.
Intended Use: The SPIDER™ (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.
Comparison with Predicate Device: The intended use of this SPIDER is identical to the predicate device, the SPIDER™ as cleared in K090902.
The technological features of the SPIDER™ are the same as the predicate. The principle of operation is the same as the predicate. The dimensions and materials used in the modified system are essentially the same as the predicate device.
Furthermore, verification and validation testing provided information sufficient to
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102839 . Page (2) of (2)
determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TransEnterix. Inc. % Ms. Bobbi L. Hadersbeck, MS Sr. RA and Compliance Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
MAR 1 5 2011
Re: K102839
Trade/Device Name: SPIDER™ Standard and Advanced Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ, GCJ Dated: February 24, 2011 Received: February 25, 2011
Dear Ms. Hadersbeck:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Bobbi L. Hadersbeck, MS
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Indications For Use Statement
Device Name: SPIDER™ Standard and Advanced
Intended Use:
The SPIDER™ (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use
Neil Re Ogden firma
(Optional Format 1-2-96)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102839
Page 51 of 57
§ 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.