(70 days)
No
The device description and intended use focus on mechanical articulation and electrosurgical capabilities, with no mention of AI or ML.
No
These devices are surgical instruments designed for manipulating tissues, grasping, clamping, cutting, and applying monopolar cautery during endoscopic, gynecological, and general laparoscopic procedures. They are tools used by surgeons, not devices that provide therapy or treatment to the patient.
No
The device description and intended use clearly state that these instruments are for manipulating, grasping, cutting, or cauterizing tissues during surgical procedures. They are interventional tools, not used for diagnosis.
No
The device description clearly outlines physical components like a pistol grip, rigid shaft, articulating end effector, jaws, and an electrocautery hook, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that these devices are surgical instruments used within the body during laparoscopic procedures for tasks like grasping, clamping, dissecting, cutting, and applying cautery. They are manipulating tissues and structures in vivo, not analyzing samples in vitro.
The text focuses on the physical manipulation of tissues and the application of energy (cautery) during surgery, which are characteristic of surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.
The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.
The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.
The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.
The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.
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 testing has been performed in support of the intended use of these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K951589, K914753, K914752, K905426, K904578
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Surgical Devices, a global business unit of Tyco Healthcare Group
5. 510(K) SUMMARY:
510(k) Summary of Safety and Effectiveness:
SEP = 1 2009
SUBMITTER: Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473
CONTACT PERSON:
Robert Zott Program Director, Regulatory Affairs Phone: (203) 492-6013 Fax: (203) 492-5029
DATE PREPARED:
Revised August 13, 2009
TRADE/PROPRIETARY NAME:
SILSTM Clincher* / SILSTM Dissector* SILSTM Grasper* / SILSTM L-Hook* SILS™ Shears*
COMMON/USUAL NAME:
Endoscopic Hand Instruments
Endoscopic Hand Instruments
CLASSIFICATION NAME:
PREDICATE DEVICE(S):
K951589: Auto Suture™ Modified Endoscopic Hand Instruments K914753: Auto Suture™ Articulating Endoscopic Clamp K914752: Auto Suture™ Articulating Endoscopic Scissors K905426: Auto Suture™ Modified Endo Stream Suction/Irrigation Device K904578: Auto Suture™ Modified Endoscopic Clamp
PRIOR RELATED SUBMISSION(S):
For Single Incision Procedures:
K090419: SILSTM Stitch Endoscopic Suturing Device
K082619: SILS™ Port Multiple Instrument Access Port
K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."
1
All predicate devices including those cleared in the prior related submissions are manufactured by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)
· DEVICE DESCRIPTION:
INDICATIONS:
Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.
The SILS™ Clincher* single use articulating clincher has application in a variety of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.
The SILSTM Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
The SILSTM Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological. and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.
The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.
The SILSTM Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
2
TECHNOLOGICAL CHARACTERISTICS:
.
.
.
.
MATERIALS:
PERFORMANCE DATA:
The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.
All patient contact materials in the SILSTM Hand Instruments have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.
In-vitro and in-vivo testing has been performed in support of the intended use of these devices.
3
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare.
: | 11:4
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Covidien LP % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06511
Re: K091869
Trade/Device Name: SILS™ Clincher*, SILS™ Dissector*, SILS™ Grasper*, SILS™ L-Hook*, SILS™ Shears*
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 13, 2009 Received: August 14, 2009
Dear Mr. Zott:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Robert Zott
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/CDRHOffices/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/cdrl/indr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Michal N. Meller
Mark N. Melkerso. Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K091869
Device Name:
Indications For Use:
SILS™ Clincher*, SILS™ Dissector*, SILS™ Grasper*, SILS™ L-Hook*, SILS™ Shears*
The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.
The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.
The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.
The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.
- Specific trade names to be determined.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. 2091865
Page 1 of __