(198 days)
Not Found
No
The device description and other sections do not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device appears to be a collection of standard laparoscopic instruments.
No
This device is a surgical instrument kit used for accessing, dissecting, manipulating, and collecting tissue during laparoscopic procedures, not for therapeutic treatment.
No
The device description indicates it is a kit of instruments for performing surgical procedures (laparoscopic access, tissue dissection, manipulation, hemostasis, specimen collection), not for diagnosing conditions.
No
The device description explicitly states it is a "convenience kit of laparoscopic instruments," which are physical tools used in surgery. 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 for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "convenience kit of laparoscopic instruments" used for "laparoscopic access, tissue dissection and manipulation, hemostasis, and specimen collection." These are all tools used during a surgical procedure on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.
Product codes
GEI
Device Description
Convenience kit of laparoscopic instruments.
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)
Relevant clinical literature has been cited in support of the intended use of this convenience kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K883018, K914753, K920599, K922123, K951589, K981941, K012539
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)
5. 510(K) SUMMARY:
510(k) Summary of Safcty 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 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Robert Zott
Program Director, Regulatory Affairs
Phone: (203) 492-6013
Fax: (203) 492-5029 |
| DATE PREPARED: | September 21, 2007 |
| TRADE/PROPRIETARY NAME: | To Be Determined |
| COMMON/USUAL NAME: | Convenience Kit |
| CLASSIFICATION NAME: | Convenience Kit |
| PREDICATE DEVICE(S): | K883018: Endo Clip* 5mm Clip Applier |
| | K914753: Roticulator Endo Dissect* 5mm,
Endo Grasp* 5mm, & Endo Mini-Shears* 5mm |
| | K920599: AcuClip* Right Angle Clip Applier |
| | K922123: Endo Catch* Gold |
| | K951589: Roticulator Endo Sciz* 5mm
Hook Scissors |
| | K981941: Dexide* 5mm Threaded Trocar |
| | K012539: VersaStep* Plus 12mm Trocar |
| | All predicate devices manufactured by
Surgical Devices, a global business of
Tyco Healthcare Group LP (d/b/a/ Covidien) |
1
072414
Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)
| DEVICE DESCRIPTION: | Convenience kit of laparoscopic instruments. |
|---|---|
| INTENDED USE: | "Single-Incision Laparoscopic Surgery and other |
| advanced laparoscopic procedures." | |
| TECHNOLOGICAL | |
| CHARACTERISTICS: | The convenience kit contains various |
| configurations of tools for the performance of | |
| laparoscopic procedures. These tools provide | |
| laparoscopic access, tissue dissection and | |
| manipulation, hemostasis, and specimen collection. | |
| MATERIALS: | Unchanged from predicate devices. |
| PERFORMANCE DATA: | Relevant clinical literature has been cited in |
| support of the intended use of this convenience kit. |
2
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2008
Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K072814
Trade/Device Name: Convenience Kit for "Single-Incision Laparoscopic Surgery and and other advanced laparoscopic procedures." Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 20, 2008 Received: March 21, 2008
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 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 or uny I vith 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
3
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.
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 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 the reporting 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. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment l
Indications for Use
| 510(k) Number (if known): | K072814 |
|---|---|
| Device Name: | Convenience Kit for "Single-Incision Laparoscopic Surgery |
| and other advanced laparoscopic procedures." | |
| Indications for Use: | For Single-Incision Laparoscopic Surgery and other |
| advanced laparoscopic procedures. |
V 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)
Neil R.P. Ogden for MXM
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K072814
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