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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Aegis Transit System, which is a medical device intended to aid surgeons in visualizing the mediastinum and facilitating surgical instrument introduction and removal. The document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical accuracy or effectiveness.

Instead, this submission focuses on demonstrating substantial equivalence to already cleared predicate devices (Aegis Surgical, Ltd., Illuminated Mediastinal Access Port, K141622 and K160171) based on technological characteristics and design modifications.

Here's why the requested information cannot be provided from this document:

Type of Device: The Aegis Transit System is a surgical access system (a mediastinoscope and accessories), not a diagnostic AI/ML device that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data. Its "performance" is primarily related to its mechanical and material properties, and its ability to provide access and visualization.
Nature of Submission: A 510(k) submission generally aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve showing improved clinical outcomes or diagnostic accuracy via large-scale clinical trials in the way an AI/ML diagnostic would.

Therefore, the following points are not applicable or cannot be extracted from this document:

A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for clinical accuracy or present data against such criteria. The "performance data" section states "No new bench testing was required" and refers to prior testing for the predicate devices, focusing on the mechanical and material changes.
Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" for performance metrics like sensitivity/specificity.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this is not an AI/ML diagnostic or image interpretation device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as there is no AI/ML component.
How the ground truth for the training set was established: Not applicable.

What the document does provide concerning "performance" and "acceptance":

The document effectively describes the changes from the predicate devices and argues that these changes do not raise new questions of safety or effectiveness. The "acceptance criteria" here are implied to be the demonstration of substantial equivalence by showing that:

The intended use is the same (with enhanced examples of procedures).
The principle of operation is the same.
Material changes (from industrial grade to medical grade polycarbonate) are considered improvements or equivalent, leveraging prior testing of the handle design.
The shelf life has been extended from 3 months to 3 years, implying successful shelf-life testing, though details are not provided in this summary.
Packaging changes are noted.

The crucial statement regarding performance is in section 1.7: "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." This indicates that the previous predicate devices' performance data (presumably related to mechanical integrity, biocompatibility, sterilization, etc.) formed the basis for accepting the current device's performance, as the changes were deemed not to impact safety or effectiveness. The modification to the small trocar handle incorporated a design cleared under K160171, and thus, previous testing of that handle was deemed sufficient.

Summary

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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.

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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 (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

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Indications for Use

510(k) Number (if known) K170757

Device Name Aegis Transit System

Indications for Use (Describe)

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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Traditional 510(k) Premarket Submission:

510(K) SUMMARY

1.1Submitter
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
1.2Device
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 Device1.3
Name of Device:	Aegis Surgical, Ltd.,
	Illuminated Mediastinal Access Port
510(k) Number:	K141622 and K160171

1.4 Device Description

. 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

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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

1.6 Comparison of Technological Characteristics with the Predicate Device

Please see the Table below.

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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 AccessPort is intended to aid the surgeon indirect visualization of themediastinum and facilitate theintroduction and removal of surgicalinstruments during surgicalprocedures.The IMAP is specifically indicatedfor use in the anterior, superior andmiddle mediastinum.	Same	The Aegis Transit System is intended to aid the surgeon in directvisualization of the mediastinum and facilitate the introduction andremoval of surgical instruments during surgical procedures (e.g.,lung, tracheal and esophageal procedures, access to aorta fortranscatheter valve procedures and/or thoracic endovascular aorticrepair).The IMAP is specifically indicated for use in the anterior, superiorand middle mediastinum.
Principle ofOperation	Provide an open channel for access tothe mediastinum and the ability tointroduce and utilize surgicalinstruments through the cannulachannel and provide access tovisualization and illumination	Same	Same	Same
Dimensions,workingchannel	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: 3.7cm x 2.9 cm	Same as K141622	Same as K160171
Materials	Cannula body/ Working Channel:Industrial grade PolycarbonateTrocar: Industrial gradePolycarbonateHandle Rod: 303 Stainless steel	Cannula body/Working Channel:Industrial grade PolycarbonateTrocar: Industrial gradePolycarbonateHandle Rod: 303 Stainless steel	Cannula body/Working Channel:Medical grade PolycarbonateTrocar: Medical gradePolycarbonateHandle Rod: 303 Stainless steel	Cannula body/WorkingChannel: Medical gradePolycarbonateTrocar: Medical gradePolycarbonate
			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

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Traditional 510(k) Premarket Submission:

Aegis Surgical, Ltd., Aegis Transit System

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K170757

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.

Regulation Number and Section

§ 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.