(271 days)
Not Found
No
The summary describes a purely mechanical and optical endoscope with no mention of computational processing, image analysis, or any terms related to AI/ML.
No.
The device is an endoscope used for visualization and dissection during surgical procedures, not for treating a disease or condition itself.
No
This device is described as an endoscope used for surgical procedures like dissection and vessel harvesting, not for diagnosing conditions.
No
The device description explicitly states it is a reusable product consisting of a stainless steel shaft housing optical and illumination components, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an endoscope used for surgical procedures within the body (in vivo). It is used for visualization and dissection of tissues during minimally invasive surgery.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient.
Therefore, the 7 mm Extended Length Endoscope with Dissection Tip is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 7 mm Extended Length Endoscope with Dissection Tip is indication of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracc space. Extremity procedures include tissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Product codes
GCJ
Device Description
The 7 mm Endoscope is a reusable product which consists of a stainless steel shaft housing optical and illumination components. The proximal end has an eyepiece for camera adapter attatchment, and a light post for light cable connection; the camera adapter and light cable are not included with the 7 mm Endoscope. The 7 mm Endoscope is supplied non-sterile, and must be cleaned and sterilized prior to each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extraperitoneal or subcutaneous extremity and thoracic space
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)
Performance Testing.
The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared 7 mm Extended Length Endoscope.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 15, 2020
MAQUET Cardiovascular, LLC Mark Dinger Sr. Regulatory Affairs Specialist 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K191930
Trade/Device Name: 7 mm Extended Length Endoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 12, 2020 Received: March 16, 2020
Dear Mark Dinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191930
Device Name
7 mm Extended Length Endoscope
Indications for Use (Describe)
The 7 mm Extended Length Endoscope with Dissection Tip is indication of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracc space. Extremity procedures include tissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
K191930
7 mm Extended Length Endoscope Reprocessing Methods
510(k) Summary
Prepared in accordance with 21 CFR Part 807.92
| 510(k) Number: | K191930 |
|---|---|
| Date Prepared: | 16 July 2019 |
| Device Owner: | MAQUET Cardiovascular, LLC. |
| 45 Barbour Pond Drive | |
| Wayne NJ 07470 | |
| United States of America | |
| Contact Personnel: | Mark Dinger |
| Title: | Sr. Regulatory Affairs Specialist |
| Email: | mark.dinger@getinge.com |
| Phone: | 973-709-7691 Fax: 973-909-9954 |
| Trade Name: | 7 mm Extended Length Endoscope |
| Device Generic Name: | Endoscope and accessories |
| Classification: | Class II |
| GCJ; Endoscope and accessories, 21 CFR 876.1500 | |
| Predicate Device: | (K014250) 7 mm Extended Length Endoscope (SE: 10 Jan 2002) |
Device Description:
The 7 mm Endoscope is a reusable product which consists of a
stainless steel shaft housing optical and illumination components.
The proximal end has an eyepiece for camera adapter attatchment,
and a light post for light cable connection; the camera adapter and
light cable are not included with the 7 mm Endoscope. The 7 mm
Endoscope is supplied non-sterile, and must be cleaned and
sterilized prior to each use.
4
| Indications for Use: | The 7 mm Extended Length Endoscope with Dissection Tip is
indicated for visualization of a surgical cavity and dissection in
endoscopic procedures and other minimally invasive surgical
procedures allowing access for vessel harvesting, and is primarily
indicated for patients undergoing endoscopic vessel harvesting for
arterial bypass. It is indicated for patients requiring endoscopic
tissue separation of the extraperitoneal or subcutaneous extremity
and thoracic space. Extremity procedures include tissue
dissection/vessel harvesting along the saphenous vein for use in
coronary artery bypass grafting and peripheral artery bypass or
radial artery for use in coronary artery bypass grafting.
Thoracoscopic procedures include exposure and dissection of
structures external to the parietal pleura, including nerves, blood
vessels and other tissues of the chest wall. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Proposed 7 mm Extended Length Endoscope and the predicate
devices have the following similarities: |
| | the same intended use, the same operating principles, incorporates the same basic design and materials, has same packaging. |
| | The Proposed 7 mm Extended Length Endoscope and the predicate
devices have the following differences: |
| | Added clarity to the Manual Cleaning method and added the
following cleaning methods to provide more flexibility
capability to the end user. Manual Cleaning with Sonication Automated Cleaning with Alkaline detergent Automated Cleaning with Enzymatic detergent Combined Automated Washing / Thermal High Level
Disinfectant (in a washer/disinfecter). Expanded method in one modality and removed a method in
another modality for sterilization. |
| | The differences are not considered a technological difference and
are substantially equivalent to the predicate device. |
5
K191930
| Safety and
Performance: | MAQUET Cardiovascular, LLC., development process required
that the following activities be completed during the development
of the 7 mm Extended Length Endoscope:
o Performance Testing |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The results of the in-vitro tests conducted demonstrate that the
functionality and performance characteristics of the device are
comparable to the previously cleared 7 mm Extended Length
Endoscope. |
| Conclusion: | Based upon the information submitted in this Traditional 510(k)
premarket notification, MAQUET Cardiovascular's 7 mm
Extended Length Endoscope is substantially equivalent to the
predicate device. The 7 mm Extended Length Endoscope is similar
to the predicate devices in the intended use and the fundamental
scientific technology of the device. The validation testing
established that the 7 mm Extended Length Endoscope is
substantially equivalent as the predicate device. |