(51 days)
Not Found
Not Found
No
The description focuses on mechanical functions and insulation, with no mention of AI/ML terms or capabilities.
No
The device is described as a surgical instrument used for grasping, dissecting, and cutting during minimally invasive procedures. It does not provide any therapeutic effect itself but assists surgical operations.
No
The device description indicates it is a surgical instrument (scissors, forceps, jaws) used for dissection or grasping during minimally invasive procedures. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a fully disposable surgical instrument with physical components like handles, triggers, shafts, and working tips. It is a hardware device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology." This describes a surgical instrument used during a procedure on a patient.
- Device Description: The description details a surgical instrument with features like handles, triggers, rotation knobs, and various tip styles (scissors, forceps, jaws). It is used to manipulate tissue or perform actions within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a tool used directly on the patient during surgery.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Encision Disposable Handle Assemblies are for use during minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.
Product codes
GCJ, HET
Device Description
The DH0100 series and DH0500 series Disposable Handle Assemblies are fully disposable surgical instruments which are packaged for use without additional setup. The instruments fit standard 5.5mm cannulas. The Disposable Handle Assemblies are available in various operative lengths and styles. Tip styles include scissors, and double action and single action forceps and jaws for dissection or grasping. The handle and trigger open and close the working tip of the instrument. The rotation knob turns to allow 360°orientation of the tip as the surgeon prefers.
This device does not transmit electrosurgical energy. There is no connection for monopolar or bipolar output from a generator. However, the shaft is insulated, in the event the instrument comes into contact with an active instrument, to prevent stray energy burns.
The assembly is supplied sterile and is not intended for more than one use.
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
Non-clinical Performance Testing: Performance of the devices' articulating functions, and shaft insulation dielectric withstand, have been verified by bench testing. Materials were selected and verified to meet the biocompatibility requirements of the applicable ISO 10993 series of standards.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
ENCISI&N
090979
510(k) Summary
DATE: April 3, 2009
510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040
Page 1 of 2
MAY 28 2009
Contact Person: Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: 303-339-6917 Fax: 303-444-2693 e-mail: jking@encision.com
Device Name: Disposable Handle Assemblies
Common name: Endoscope and Accessories
Classification: CFR Section: 876.1500. Secondary classification: 884.1720
Class: II
Product Code: GCJ
Predicate Devices:
| Trade, Proprietary or Model Name | Manufacturer |
|---|---|
| Shielded Laparoscopic Monopolar Electrodes | Encision Inc. |
| "Take Apart®" Insulated Forceps, Biopsy Forceps, | |
| Scissors | Karl Storz Endoscopy America Inc. |
| Laparoscopic Scissors | Applied Medical Resources Corp. |
| Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. |
Description of Devices:
The DH0100 series and DH0500 series Disposable Handle Assemblies are fully disposable surgical instruments which are packaged for use without additional setup. The instruments fit standard 5.5mm cannulas. The Disposable Handle Assemblies are available in various operative lengths and styles. Tip styles include scissors, and double action and single action forceps and jaws for dissection or grasping. The handle and trigger open and close the working tip of the instrument. The rotation knob turns to allow 360°orientation of the tip as the surgeon prefers.
This device does not transmit electrosurgical energy. There is no connection for monopolar or bipolar output from a generator. However, the shaft is insulated, in the event the instrument comes into contact with an active instrument, to prevent stray energy burns.
The assembly is supplied sterile and is not intended for more than one use.
1
Page 2 of ②
Intended Use:
ﮐ
The Encision Disposable Handle Assemblies are for use during minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.
Contraindications
- These instruments have not been shown to be effective for tubal sterilization procedures, . and should not be used for these procedures.
- These instruments are not intended for use when minimally invasive techniques are . contraindicated.
Technological Characteristics:
The Encision Disposable Handle Assemblies incorporate the same technological characteristics as the predicate devices, with the exception that no option is provided for connection to a high frequency electrosurgical energy source. The cutting and tissue manipulation features, however, perform in an equivalent manner, and the handle articulation is transmitted to the tips in the same way. The shaft of the instrument is also insulated. The single use device is packaged assembled and shipped sterile.
Non-clinical Performance Testing:
Performance of the devices' articulating functions, and shaft insulation dielectric withstand, have been verified by bench testing.
Materials were selected and verified to meet the biocompatibility requirements of the applicable ISO 10993 series of standards.
Conclusions:
The Encision Disposable Handle Assemblies are safe and effective and are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three overlapping wings or feathers.
Public Health Service
MAY 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encision, Incorporated % Ms. Judith V. King Vice President Regulatory Affairs & Quality Assurance 6797 Winchester Circle Boulder, Colorado 80301
Re: K090979
Trade/Device Name: Disposable Handle Assemblies Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ Dated: April 3, 2009 Received: April 7, 2009
Dear Ms. King:
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
3
Page 2-Ms. Judith V. King
(reporting of medical 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 your
Mark N. Melkerson
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Disposable Handle Assemblies
Indications for Use:
The Encision Disposable Handle Assemblies are used for minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
―― ・ ・ = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Neil R.L. Ogden Forman
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090779
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