(15 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and electrical safety, sterilization, and biocompatibility of manual surgical instruments. There is no mention of AI or ML capabilities.
No.
The device is a surgical instrument used to perform cutting, dissecting, retracting, and manipulating functions during endoscopic surgical procedures. It is not intended to treat or cure a disease or condition.
No
This device is described as a surgical instrument used for cutting, dissecting, retracting, and manipulating tissues during endoscopic procedures. Its function is to perform surgical actions, not to diagnose conditions.
No
The device description clearly states it is a manual surgical instrument with physical components (handles, insulation, inserts) and mentions mechanical and electrical safety testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions." This describes a surgical instrument used on the patient's body during a procedure.
- Device Description: The description further reinforces this by stating it's a "Laparoscopic surgical manual instrument" for "cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health. This device does not perform any such analysis of specimens.
- Performance Studies: The performance studies listed (Biocompatibility, Sterilization Validation, Electrical Safety, Mechanical Testing) are typical for surgical instruments, not IVD devices.
Therefore, based on the provided information, the Laparoscopic Handles with PEEK Insulation are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Laparoscopic surgical manual instruments (containing a Laparoscopic Handle with PEEK Insulation and manual instrument insert) are intended for cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries such as suturing material. Some instruments have radiofrequency (RF) ports which allow them to be used for electrosurgery. The Laparoscopic Handles with PEEK Insulation (herein referred to as 'proposed device') can be used in combination with the predicate 5 mm inserts cleared in K973259. The proposed devices are designed to be sterilized by the end user using either the US or EU standard pre-vacuum sterilization cycles.
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)
Biocompatibility Testing:
The biocompatibility evaluation and testing of the Laparoscopic Handles with PEEK Insulation was conducted in accordance with the following as recognized by the FDA:
- FDA Blue Book Memorandum #G95-1 "Use of International Standard 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" May 1, 1995,
- ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,"
- ISO 10993-5. Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic ● toxicity.
The Laparoscopic Handles with PEEK Insulation are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2015
Stryker Endoscopy % Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockafeller Plaza New York, New York 10111
Re: K150127
Trade/Device Name: Laparscopic Handles with PEEK Insulation Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 19, 2015 Received: January 20, 2015
Dear Mr. Yungvirt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Jennifer R. Stevenson -A for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150127
Device Name
Laparoscopic Handles with PEEK Insulation
Indications for Use (Describe)
The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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I. SUBMITTER
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138
Phone: 408-855-6377 Fax: 408-754-2969
Contact Person: Rebecca Goldberg Date Prepared: January 16, 2015
II. DEVICE
Name of Device: Laparoscopic Handles with PEEK Insulation Common or Usual Name: Endoscopic Forceps/Graspers/Scissors Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: GCJ
III. PREDICATE DEVICE
K&W 2-Piece Take-Apart Instruments, K973259
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Laparoscopic surgical manual instruments (containing a Laparoscopic Handle with PEEK Insulation and manual instrument insert) are intended for cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries such as suturing material. Some instruments have radiofrequency (RF) ports which allow them to be used for electrosurgery. The Laparoscopic Handles with PEEK Insulation (herein referred to as 'proposed device') can be used in combination with the predicate 5 mm inserts cleared in K973259. The proposed devices are designed to be sterilized by the end user using either the US or EU standard pre-vacuum sterilization cycles.
INDICATIONS FOR USE V.
The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, and manipulating functions.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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Manipulation and cutting of tissue using mechanical or electrosurgical means is the technological principle for both the proposed and predicate devices. These functions are based on using surgical tools to access internal tissues and organs within the abdominal cavity.
The following differences exist between the proposed and predicate devices:
- Use of different shaft insulation material .
- . Use of different glue between the shaft and shaft insulation
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The biocompatibility evaluation and testing of the Laparoscopic Handles with PEEK Insulation was conducted in accordance with the following as recognized by the FDA:
- . FDA Blue Book Memorandum #G95-1 "Use of International Standard 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" May 1, 1995,
- ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,"
- . ISO 10993-5. Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic ● toxicity.
The Laparoscopic Handles with PEEK Insulation are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (