(23 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to predicate devices, with no mention of AI or ML.
No.
The device is a trocar, which is used to create and maintain a port of entry for endoscopic procedures; it does not directly treat a disease or condition.
No
The device description indicates it is a surgical tool (trocar) used to create and maintain a port of entry for endoscopic procedures, not to diagnose a condition.
No
The device description clearly details a physical medical device (trocar with fixation sleeve) with various sizes and mechanical components (blade, shield, seal, stopcock valve). It is 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 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 surgical access.
- Device Description: The description details a physical instrument with a blade, shield, sleeve, and seals, designed for surgical insertion and access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health, diagnose conditions, or monitor treatment.
IVD devices are specifically designed for testing biological samples outside the body. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve 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™ Modified VERSAPORT™ trocar with fixation sleeve is available in 5 mm short length, 5 mm regular length, 11 mm regular length, 12 mm regular length, and 12 mm long length sizes. The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve has a sharp linear blade with a spring-loaded locking shield. Upon entry into a free space the shield advances to cover the blade, reducing the potential for injury to internal structures. The trocar sleeve contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The VERSASEAL™ self-adjusting seal accommodates instruments ranging from 5 mm to 12 mm and is designed to effectively reduce the seal diameter to allow insertion of smaller 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 autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is substantially equivalent to the predicate devices in creation and maintaining a port of entry and to validate that the creation and maintaining a per of only a trocar with fixation sleeve will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
autosuture™ VERSAPORT trocar, Ethicon Endopath™ III Dilating tip Trocar
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
K 062326
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP
150 Glover Avenue
Norwalk, CT 06856
Tel. No.: (203) 845-1000 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SEP - 1 2006 |
| CONTACT PERSON: | Daniel Campion
Associate, Regulatory Affairs |
| DATE PREPARED: | August 7, 2006 |
| TRADE/PROPRIETARY NAME: | autosuture™ Modified VERSAPORT™ trocar with fixation
sleeve |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| PREDICATE DEVICE(S): | autosuture™ VERSAPORT trocar, Ethicon Endopath™ III
Dilating tip Trocar |
| DEVICE DESCRIPTION: | The autosuture™ Modified VERSAPORT™ trocar with fixation
sleeve is available in 5 mm short length, 5 mm regular length,
11 mm regular length, 12 mm regular length, and 12 mm long
length sizes. The autosuture™ Modified VERSAPORT™ trocar
with fixation sleeve has a sharp linear blade with a spring-
loaded locking shield. Upon entry into a free space the shield
advances to cover the blade, reducing the potential for injury to
internal structures. The trocar sleeve contains an internal seal
to prevent loss of pneumoperitoneum when instruments are
inserted or withdrawn. The VERSASEAL™ self-adjusting seal
accommodates instruments ranging from 5 mm to 12 mm and
is designed to effectively reduce the seal diameter to allow
insertion of smaller instruments. There is a stopcock valve for
insufflation and rapid desufflation. |
| INTENDED USE: | The autosuture™ Modified VERSAPORT™ trocar with
fixation sleeve is intended for use in a variety of
gynecologic, general, thoracic and urologic endoscopic
procedures to create and maintain a port of entry. |
| TECHNOLOGICAL
CHARACTERISTICS: | The autosuture™ Modified VERSAPORT™ is identical to the
predicate devices in terms of its intended use. The device will
now be offered with a fixation sleeve and beveled tip. |
| MATERIALS: | All components of the autosuture™ Modified VERSAPORT™
trocar with fixation sleeve 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
autosuture™ Modified VERSAPORT™ trocar with fixation
sleeve is substantially equivalent to the predicate devices in |
| United States Surgical | Page 22 |
1
creation and maintaining a port of entry and to validate that the creation and maintaining a per of only a trocar with fixation sleeve will perform as intended.
2
Image /page/2/Picture/1 description: The image contains a logo for the Department of Health and Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, stacked on top of each other. To the left of the logo, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically, with the letters rotated 90 degrees counterclockwise.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2006
United States Surgical % Mr. Daniel Campion Associate, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856
Re: K062326
Trade/Device Name: autosuture™ Modified VERSAPORT™ trocar with fixation sleeve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 8, 2006 Received: August 9, 2006
Dear Mr. Campion:
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. Daniel Campion
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
tur PJok
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known): K C 6 2 3 2 b
Device Name: autosuture™ Modified VERSAPORT™ trocar with fixation sleeve
Indications For Use:
The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve 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 × (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
0 C
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
United States Surgical Premarket Notification
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