(13 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a surgical seal and cannula, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a surgical access tool (trocar/cannula) used to create a path for other instruments during minimally invasive surgery and is not described as treating or curing a disease or condition itself.
No
The device is described as an access port for surgical instruments, not for diagnosing conditions.
No
The device description clearly states it is "assembled with an Intuitive Surgical cannula" and "placed over an incision," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to create access for instruments. This is a surgical access device, not a device used to examine specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details how the device is used to gain access through tissue layers during surgery. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural within the surgical setting.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments
Product codes
GCJ
Device Description
The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.
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
The performance and functional testing of the Intuitive Surgical Seal included tests to verify the inflation and leakage as compared to its predicate device. The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
Key Metrics
Not Found
Predicate Device(s)
Applied Medical Modular Trocar (K932995)
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.
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MAR 1 3 2006
510(k) SUMMARY
510(k) NUMBER: PENDING
SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000
- CONTACT PERSON: Cheryl Blake Vice President, Regulatory Affairs and Quality Systems
DATE OF PREPARATION: January 20, 2006
NAME OF DEVICE: Intuitive Surgical Seal
CLASSIFICATION NAME:Laparoscope, General & Plastic Surgery (21CFR 876.1500)
| TRADE NAME: | Intuitve Surgical Seal |
|---|---|
| PREDICATE DEVICE: | Applied Medical Modular Trocar (K932995) |
| Applied Medical, Rancho Santa Margarita, CA |
INTENDED USE: DESCRIPTION/INDICATIONS:
The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments
DEVICE DESCRIPTION: The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.
PERFORMANCE DATA SUMMARY: The performance and functional testing of the Intuitive Surgical Seal included tests to verify the inflation and leakage as compared to its predicate device. The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line. The text is black against a white background.
Image /page/1/Picture/2 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized with flowing lines, giving it a sense of movement and dynamism. The overall design is simple and elegant, conveying a sense of authority and trustworthiness.
MAR 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Applied Medical Resources Corporation c/o Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 East Trimble Road San Jose, California 95131-1230
Re: K060534
Trade/Device Name: Intuitive Surgical Seal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 27, 2006 Received: February 28, 2006
Dear Mr. Christensen:
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 sct
2
Page 2 - Mr. Morten Simon Christenscn
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. 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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melk Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Intuitive Surgical Seal
Indications for Use:
The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
el.moll
Division of General, Restorative. and Neurological Devices
KOGOE34 510(k) Number_