(30 days)
Not Found
No
The device description focuses on mechanical components and illumination, with no mention of AI/ML capabilities or data processing.
No
The device is an access port designed to facilitate surgical procedures by providing visualization and instrument access; it does not directly treat a disease or condition.
No
The device is described as a tool for surgical access and visualization, not for identifying a disease or condition.
No
The device description clearly outlines physical components like a cannula, fiber optic bundles, handle, and trocar, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid the surgeon in direct visualization and facilitate the introduction/removal of surgical instruments during surgical procedures. This is a surgical access and visualization tool, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a surgical instrument (trocar/cannula system) with features for illumination and access. It does not mention any components or functions related to testing or analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.
The device is clearly intended for direct surgical intervention and visualization within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
Product codes
EWY
Device Description
Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar.
The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation.
The entire device is disposable, single use and provided pre-sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mediastinum, anterior, superior and middle mediastinum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
The dimensional/user interface modifications from the predicate device were evaluated by performing a cadaveric usability study. The results of the study concluded that the changes to the device did not adversely affect its safety, effectiveness, or intended use.
Packaging validation and distribution simulation testing were performed to validate seal strength and package integrity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4720 Mediastinoscope and accessories.
(a)
Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Aegis Surgical Ltd. Mr. Robert Hefter Product Development Manager 4020 Stirrup Creek Drive Suite 115 Durham, NC 27703
Re: K160171
Trade/Device Name: Illuminated Mediastinal Access Port Regulation Number: 21 CFR 874.4720 Regulation Name: Mediastinoscope and Accessories Regulatory Class: Class II Product Code: EWY Dated: January 20, 2016 Received: January 27, 2016
Dear Mr. Hefter:
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.
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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 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 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. 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
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.
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160171
Device Name Illuminated Mediastinal Access Port
Indications for Use (Describe)
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K160171 Aegis's Illuminated Mediastinal Access Port
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Aegis Surgical, Ltd. 4020 Stirrup Creek Drive - Suite 115 Durham, NC 27703 USA Phone: (919) 303-6865
Contact Person: Robert P. Hefter
Date Prepared: 02/26/2016
Name of Device and Name/Address of Sponsor
Proprietary Name: Illuminated Mediastinal Access Port
Common/Usual Name: Mediastinoscope, Surgical
Classification Name: Mediastinoscope and accessories
Predicate Devices
| Manufacturer | Trade/Model Name | 510K Number |
|---|---|---|
| Aegis Surgical Ltd. | Illuminated Mediastinal Access Port | |
| Model #: 900-01200 | K141622 |
Purpose of the Special 510(k) notice.
The Illuminated Mediastinal Access Port is a modification to previously cleared Aegis' Illuminated Mediastinal Access Port.
Device Description
Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar.
The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device
4
does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation.
The entire device is disposable, single use and provided pre-sterilized.
Intended Use
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
Technological Characteristics
The Illuminated Mediastinal Access Port is a trocar/cannula system used to provide surgical access to and direct visualization of the mediastinum to facilitate the introduction and removal of surgical instruments during surgical procedures.
The device includes a blunt trocar for dissecting tissue planes. The open cannula provides for direct visualization of the surgical space.
The base of the cannula has fiber optic bundles incorporated that may be connected to a standard LED endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a fiber optic light cable or a light source.
The trocar/cannula access device also includes a handle for connection to a support arm. This allows the Mediastinal Access Port to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinal Access Port and to provide stability for the Mediastinal Access Port during operation.
The entire device is disposable, single use and is provided pre-sterilized.
Performance Testing
The dimensional/user interface modifications from the predicate device were evaluated by performing a cadaveric usability study. The results of the study concluded that the changes to the device did not adversely affect its safety, effectiveness, or intended use.
Packaging validation and distribution simulation testing were performed to validate seal strength and package integrity.
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Substantial Equivalence
Illuminated Mediastinal Access Port has the same intended use and similar indications, principles of operation, and technological characteristics as Aegis previously cleared Illuminated Mediastinal Access Port. The minor differences in the dimensions and design do not raise any new questions of safety or effectiveness. Thus, Illuminated Mediastinal Access Port is substantially equivalent to its predicate devices.