(29 days)
Not Found
Not Found
No
The summary describes a mechanical surgical instrument (trocar) and its physical characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is described as a trocar used to create and maintain a port of entry for endoscopic procedures, not to treat a disease or condition.
No
Explanation: The device creates and maintains a port of entry for endoscopic procedures; it does not diagnose medical conditions.
No
The device description clearly describes a physical, hardware-based medical device (trocar) with various sizes, lengths, and features like a stopcock valve. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create and maintain a port of entry" for endoscopic procedures. This is a surgical tool used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (trocar) used for surgical access, not for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The autosuture™ VERSAPORT™ PLUS Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Product codes
GCJ
Device Description
The autosuture™ VERSAPORT™ PLUS Bladeless trocar is available in diameters from 5mm to 15mm, including short, standard and long length cannula. The 5mm VERSAPORT™ fixed seal system accommodates 5mm instruments, while the VERSAPORT™ PLUS removable seal systems accommodate instruments ranging from 5 mm to 15 mm (the 10/15mm system includes a converter for 5 mm diameter instruments). There is a stopcock valve for insufflation and rapid desufflation.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro and in-vivo tests were performed to verify that the performance of the autosuture™ VERSAPORT™ PLUS Bladeless trocar is substantially equivalent to the predicate devices, and to validate that the autosuture™ VERSAPORT™ PLUS Bladeless trocar will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
autosuture™ VERSAPORT, Ethicon Excel™
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
Ko81169
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Surgical Devices, a global business unit
of Tyco Healthcare Group LP (d/b/a Covidien)
60 Middletown Avenue
North Haven, CT 06473 USA | MAY 23 2008 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Tim M. Lohnes, Manager, Regulatory Affairs | |
| DATE PREPARED: | April 28, 2008 | |
| TRADE/PROPRIETARY NAME: | autosuture™ VERSAPORT™ PLUS Bladeless Trocar | |
| COMMON/USUAL NAME: | Surgical Trocar | |
| CLASSIFICATION NAME: | Endoscope and Accessories | |
| PREDICATE DEVICE(S): | autosuture™ VERSAPORT, Ethicon Excel™ | |
| DEVICE DESCRIPTION: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar is
available in diameters from 5mm to 15mm, including short,
standard and long length cannula. The 5mm VERSAPORT™
fixed seal system accommodates 5mm instruments, while the
VERSAPORT™ PLUS removable seal systems accommodate
instruments ranging from 5 mm to 15 mm (the 10/15mm
system includes a converter for 5 mm diameter instruments).
There is a stopcock valve for insufflation and rapid
desufflation. | |
| INTENDED USE: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar
is intended for use in a variety of gynecologic, general,
thoracic and urologic endoscopic procedures to create and
maintain a port of entry. | |
| TECHNICAL
CHARACTERISTICS: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar with
and/or without fixation sleeve is equivalent to the predicate
devices in terms of its intended use. The autosuture™
VERSAPORT™ PLUS Bladeless trocar obturator has 2 linear
non-bladed fins, a non-bladed rounded pin tip, and a spring-
loaded shield. The trocar sleeve housing contains an internal
seal to prevent loss of pneumoperitoneum when instruments
are inserted or withdrawn. The device will be offered with
and/or without a fixation sleeve. | |
| MATERIALS: | All components of the autosuture™ VERSAPORT™ PLUS
Bladeless trocar are comprised of materials which are in
accordance with ISO Standard 10993-1. | |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the
performance of the autosuture™ VERSAPORT™ PLUS
Bladeless trocar is substantially equivalent to the predicate
devices, and to validate that the autosuture™ VERSAPORT™
PLUS Bladeless trocar will perform as intended. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Covidien LP % Mr. Tim M. Lohnes Manager, Regultory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K081169
Trade/Device Name: autosuture™ Bladeless VERSAPORT™ PLUS trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 21, 2008 Received: April 24, 2008
Dear Mr. Lohncs:
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. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
2
Page 2 - Mr. Tim M. Lohnes
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 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 Millman
Mark N. Melkerson 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:
autosuture™ Bladeless VERSAPORT™ PLUS trocar
Indications For Use:
The autosuture™ VERSAPORT™ PLUS Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
ce of CDRH, Office of Device Evaluation (ODE) or nim Division of General, Restorative and Neurological Devices
Covidien Profes
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