(112 days)
Not Found
No
The device description and intended use describe standard mechanical endoscopic instruments (clamps, forceps, needle holders, scissors) made of stainless steel. There is no mention of any software, image processing, or AI/ML capabilities. The predicate device is also a set of similar mechanical instruments.
No
The device, Wexler Endoscope Accessories, is described as surgical instruments (clamps, forceps, scissors, needle holders) used for minimally invasive handling, grasping, cutting, and suturing during endoscopic procedures. These are operative tools, not devices that provide therapy or treatment to a patient's condition.
No
The device description states that the tools are used to "grasp tissue or other items," "cut tissue," and for "suturing." These are all interventional actions, not diagnostic ones.
No
The device description explicitly states the instruments are made of stainless steel, indicating they are physical hardware devices, not software.
Based on the provided information, the Wexler Endoscope Accessories are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that these devices are used in endoscopic surgical procedures to provide minimally invasive handling of tissue and other items in the surgical field. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The description confirms they are instruments used during endoscopic procedures and are made of stainless steel.
- Lack of IVD Characteristics: There is no mention of these devices being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue samples.
Therefore, the Wexler Endoscope Accessories are surgical instruments used in vivo (within the body) during endoscopic procedures, not IVD devices.
N/A
Intended Use / Indications for Use
The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.
Product codes
GCJ
Device Description
The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.
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)
Not Found
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.
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.
Not Found
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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Part 807.92.
Submitter's Name: Microsurgical Laboratories, dba Wexler Surgical Supplies 11333 Chimney Rock Road, Suite 110 Houston, TX 77035 Telephone: (713) 723-6900 Fax: (713) 723-6906 Contact person: Mr. Danny Fishman, COO
Date of Summary: March 29, 2011
Device Names:
Trade Name, Common Name: Endoscope accessories, various Classification Name: Endoscope accessories (21 CFR, Part 876.1500, GCJ)
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate devices are the Scanlan® thoracoscopic scissors, clamp, forceps, and needle holder (K945474) manufactured by Scanlan International, Inc., determined to be substantially equivalent to a legally marketed (preAmendment) device on December 5, 1994.
Device Description: The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.
Intended Use: The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The indications for use, principles of operation, and device design of the Wexler Endoscope Accessories are virtually identical to those of the predicate devices, the Scanlan thoracoscopic instruments. Both series of devices are made of stainless steel, and share technological characteristics common to all instruments of their types. There are no significant differences in either technology or performance specifications. The Wexler Endoscope Accessories devices are supplied non-sterile, and the devices are subjected by the user to the sterilization cycle specified by the institution.
Conclusion: The information and data provided in this 510(k) Notification establish that the Wexler Endoscope Accessories is substantially equivalent to the legally marketed predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 0 2011
Microsurgical Laboratories, Inc., dba Wexler Surgical Supplies % Device for the Future Ms. Lisa S. Jones 540 College Street Bellaire, Texas 77401
Re: K110121
Trade/Device Name: Wexler Endoscope Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 02, 2011 Received: May 03, 2011
Dear Ms. Jones:
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.
2
Page 2 - Ms. Lisa S. Jones
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 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/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 Small Manufacturers, International and Consumer Assistance 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,
Aty B. R. la
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K110121
Device Name: Wexler Endoscope Accessories
Indications for Use: The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
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. Boyle for mkm
(Division Sign-Off)
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110121