(123 days)
No
The device description focuses on physical modifications and labeling changes to previously cleared devices. There is no mention of AI, ML, or any software-driven analytical capabilities.
No
The device is intended to aid the surgeon in direct visualization and facilitate the introduction and removal of surgical instruments, not to treat a disease or condition itself.
No
The device is intended to aid the surgeon in direct visualization and facilitate the introduction and removal of surgical instruments, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description explicitly details physical components (trocar, cannula, handle, packaging) and material changes (polycarbonate), indicating it is a hardware device, not software-only.
Based on the provided text, the Aegis Transit System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures." This describes a surgical access and visualization tool used during a surgical procedure on a patient.
- Device Description: The description details physical components like ports, trocars, cannulas, and packaging. These are all physical instruments used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to perform tests on samples taken from the body, not to directly interact with the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).
The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.
Product codes
EWY
Device Description
The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:
- . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
- The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
- . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
- . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
- . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.
Both devices are being used in accordance with their cleared indications for use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No new bench testing was required for an assessment of substantial equivalence; the bench testing submitted and reviewed under K141622 and K160171 is applicable to the proposed Aegis Transit System. The only design change was made to the small (dissecting) trocar, which was modified to incorporate the ergonomic handle that was cleared with the large (delivery) trocar in K160171. Both this change and the proposed labeling change have no impact on the intended use of the device. Therefore, the testing completed in support of the ergonomic handle for the large (delivery) trocar (K160171) is adequate to support the use of the ergonomic handle in the small (dissecting) trocar.
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
§ 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.
0
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Boston-Biomedical Associates Lauren Baker President and CEO 100 Crowley Drive, Suite 216 Marlborough, MA 01752
Re: K170757
Trade/Device Name: Aegis Transit System Regulation Number: 21 CFR 874.4720 Regulation Name: Mediastinoscope and Accessories Regulatory Class: Class II Product Code: EWY Dated: June 15, 2017 Received: June 16, 2017
Dear Lauren Baker:
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.
1
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 devicerelated 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,
Eric A. Mann -S
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
2
Indications for Use
510(k) Number (if known) K170757
Device Name Aegis Transit System
Indications for Use (Describe)
The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).
The Aegis Transit System 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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3
Traditional 510(k) Premarket Submission:
510(K) SUMMARY
| 1.1
| Submitter | ||
|---|---|---|
| Company: | Aegis Surgical, Ltd. | |
| 4020 Stirrup Creek Drive – Suite 115 | ||
| Durham, NC 27703 | ||
| Phone: | (508) 351-8632 Ext: 201 | |
| Contact Person: | Lauren S. Baker, PhD | |
| Date Prepared: | March 10, 2017 | |
| 1.2 | ||
| Device | ||
| Name of Device: | Aegis Transit System | |
| Common or Usual | Mediastinoscope, Surgical | |
| Name: | ||
| Classification Name: | 21 CFR 874.4720, Mediastinoscope and accessories | |
| Regulatory Class: | Class II | |
| Product Code: | EWY | |
| Predicate Device | ||
| 1.3 | ||
| Name of Device: | Aegis Surgical, Ltd., | |
| Illuminated Mediastinal Access Port | ||
| 510(k) Number: | K141622 and K160171 |
1.4 Device Description
The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:
- . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step
K170757
4
Aegis Surgical, Ltd., Aegis Transit System
system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
- The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
- . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
- . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
- . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.
Both devices are being used in accordance with their cleared indications for use.
Indications for Use 1.5
The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair). The Aegis Transit System is specifically intended for use in the anterior, superior and middle mediastinum.
1.6 Comparison of Technological Characteristics with the Predicate Device
Please see the Table below.
5
Traditional 510(k) Premarket Submission:
Aegis Surgical, Ltd., Aegis Transit System
Table 1-1 Comparison of Technological Characteristics
| Aegis Transit System | ||||
|---|---|---|---|---|
| Aegis Surgical Illuminated | Aegis Surgical Illuminated | Proposed | ||
| Characteristic | Mediastinoscope | Mediastinoscope | Illuminated Mediastinal | Illuminated Mediastinal |
| K141622 | K160171 | Access Port: | Access Port: | |
| small (dissecting) trocar | large (delivery) trocar | |||
| 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 IMAP is specifically indicated | ||||
| for use in the anterior, superior and | ||||
| middle mediastinum. | Same | The Aegis Transit System is intended to aid the surgeon in direct | ||
| visualization of the mediastinum and facilitate the introduction and | ||||
| removal of surgical instruments during surgical procedures (e.g., | ||||
| lung, tracheal and esophageal procedures, access to aorta for | ||||
| transcatheter valve procedures and/or thoracic endovascular aortic | ||||
| repair). | ||||
| The IMAP is specifically indicated for use in the anterior, superior | ||||
| and middle mediastinum. | ||||
| Principle of | ||||
| Operation | Provide an open channel for access to | |||
| the mediastinum and the ability to | ||||
| introduce and utilize surgical | ||||
| instruments through the cannula | ||||
| channel and provide access to | ||||
| visualization and illumination | Same | Same | Same | |
| Dimensions, | ||||
| working | ||||
| channel | Working Channel Length: 8 cm | |||
| (10.5 cm including trocar depth) | ||||
| Outer dimensions of cannula: | ||||
| 3.3 cm x 2.1 cm (w x h) | Working Channel Length: 10 cm | |||
| (12.5cm including trocar depth) | ||||
| Outer dimensions of cannula: 3.7 | ||||
| cm x 2.9 cm | Same as K141622 | Same as K160171 | ||
| Materials | Cannula body/ Working Channel: | |||
| Industrial grade Polycarbonate | ||||
| Trocar: Industrial grade | ||||
| Polycarbonate | ||||
| Handle Rod: 303 Stainless steel | Cannula body/Working Channel: | |||
| Industrial grade Polycarbonate | ||||
| Trocar: Industrial grade | ||||
| Polycarbonate | ||||
| Handle Rod: 303 Stainless steel | Cannula body/Working Channel: | |||
| Medical grade Polycarbonate | ||||
| Trocar: Medical grade | ||||
| Polycarbonate | ||||
| Handle Rod: 303 Stainless steel | Cannula body/Working | |||
| Channel: Medical grade | ||||
| Polycarbonate | ||||
| Trocar: Medical grade | ||||
| Polycarbonate | ||||
| Aegis Transit System | ||||
| Aegis Surgical Illuminated | Aegis Surgical Illuminated | Proposed | ||
| Characteristic | Mediastinoscope | Mediastinoscope | Illuminated Mediastinal | Illuminated Mediastinal |
| K141622 | K160171 | Access Port: | Access Port: | |
| small (dissecting) trocar | large (delivery) trocar | |||
| Suture Ring: Nylon 6/6 | rod | rod | Handle Rod: 303 Stainless | |
| Fiber optic bundles: Encased in | Cannula Back Handle: Nylon 6/6 | Cannula Back Handle: Nylon | steel rod | |
| silicone with an Ultem connector | Fiber optic bundles: Encased in | ୧/୧ | Cannula Back Handle: Nylon | |
| silicone with an Ultem connector | Fiber optic bundles: Encased in | ୧/୧ | ||
| silicone with an Ultem connector | Fiber optic bundles: Encased in | |||
| silicone with an Ultem | ||||
| connector | ||||
| Shelf Life | 3 months | 3 months | 3 years | 3 years |
| Open access channel to the | ||||
| mediastinum to pass surgical | ||||
| Access | instruments. Adequate width | Same | Same | Same |
| incorporated within the cannula's | ||||
| channel dimensions. | ||||
| Visualization | Direct visualization through open | Same | Same | Same |
| channel cannula | ||||
| Illumination | Yes | Same | Same | Same |
| Sterilization | EO, Single use, pre-sterilized | Same | Same | Same |
| Packaging | Nylon/Tyvek heat sealed pouch. | Same | PETG Tray with Tyvek Lid | PETG Tray with Tyvek Lid |
| Surgical | ||||
| Support Arm | Yes | Yes | Yes | Yes |
| Connection |
6
Traditional 510(k) Premarket Submission:
Aegis Surgical, Ltd., Aegis Transit System
7
1.7 Performance Data
No new bench testing was required for an assessment of substantial equivalence; the bench testing submitted and reviewed under K141622 and K160171 is applicable to the proposed Aegis Transit System. The only design change was made to the small (dissecting) trocar, which was modified to incorporate the ergonomic handle that was cleared with the large (delivery) trocar in K160171. Both this change and the proposed labeling change have no impact on the intended use of the device. Therefore, the testing completed in support of the ergonomic handle for the large (delivery) trocar (K160171) is adequate to support the use of the ergonomic handle in the small (dissecting) trocar.
1.8 Conclusions
The proposed Aegis Transit System utilizes the two predicate devices, the Illuminated Mediastinal Access Ports, within their cleared intended use. The Aegis Transit System may be found to be substantially equivalent to the predicate Illuminated Mediastinal Access Ports.