K Number

Device Name

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

Manufacturer

Interscope, Inc.

Date Cleared

2019-12-13

(269 days)

Product Code

ERL

Regulation Number

874.4250

Intended Use

The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

Device Description

The EndoRotor® Airway Microdebridement System is a powered resection tool consisting of a power Console with Foot Control, Specimen Trap with pre-loaded filter, and a singleuse Catheter with a cutting tool mounted on the distal end. The EndoRotor's flexible design allows it to be used within the working channel of flexible bronchoscopes in tortuous paths. The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K041413

Reference Devices

K181127

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical resection tool with a console, foot control, and catheter. There is no mention of AI/ML in the device description, intended use, or performance studies. The performance studies focus on mechanical and functional testing, not algorithmic performance.

Therapeutic

Yes
The device is intended for the removal of granulation tissue and endobronchial lesions in airway procedures, which are therapeutic interventions.

Diagnostic

No.
The device is described as a "powered resection tool" intended for the removal of tissue and lesions, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components including a power Console with Foot Control, Specimen Trap, and a single-use Catheter with a cutting tool. The performance studies also describe physical and mechanical testing of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the EndoRotor® System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "airway procedures including removal of granulation tissue and endobronchial lesions." This describes a surgical or interventional procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
Device Description: The device is a "powered resection tool" with a "cutting tool" and "aspiration." This is consistent with a surgical device used to remove tissue.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples in vitro), detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EndoRotor® System is a therapeutic device used for tissue removal during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

Product codes

ERL

Device Description

The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway (including granulation tissue and endobronchial lesions)

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)

The EndoRotor® Airway Microdebridement System was verified and validated through a series of physical and mechanical performance tests on the Catheter and Console.
Non-Clinical Performance Testing:
EndoRotor® Catheter: Biocompatibility, Sterilization validation, Pyrogenicity, Shelf-life, Packaging validation, Transport testing, Functional testing*. Met established acceptance criteria.
EndoRotor® Console: Design verification testing, Power-up and Set-up Testing, Functional Testing, Electrical Safety and Electromagnetic Compatibility Testing. Met established acceptance criteria.
Procedural Testing: Specimen Trap: EndoRotor® was evaluated to determine that when proper procedure is followed as provided in the labeling, including a post procedure flush, there is no residual specimen in the Catheter.

*Includes functional performance testing of the EndoRotor® Catheter developed for airway procedures. The evidence supports the clinical performance of EndoRotor for airway debridement.

No clinical study was conducted to support the 510(k) Premarket Notification. The EndoRotor has been cleared for use in the gastrointestinal system (K181127). The safety and performance of the EndoRotor has been demonstrated for use throughout the alimentary tract. consisting of mucosa/submucosa/muscularis propria, have higher risk to injury with cutting instruments.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041413

Reference Device(s)

K181127

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

December 13, 2019

Interscope, Inc. Cynthia Nolte Director. Regulatory ICON Clinical Research, LLC 2100 Pennbrook Parkway North Wales, Pennsylvania 19454

Re: K190715

Trade/Device Name: EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: November 11, 2019 Received: November 12, 2019

Dear Cynthia Nolte:

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 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 (QS) 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 medical devices and radiation-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,

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K190715

Device Name

EndoRotor Airway Debridement System

Indications for Use (Describe)

The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

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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K190715

510(K) SUMMARY

EndoRotor® Airway Microdebridement System (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

Interscope, Inc. 100 Main Street, Suite 108 Whitinsville, MA 01588 +1 877-420-7299 Phone:

Contact:	Jeffery Ryan, Co-Founder, President & CEO
Contact Phone:	617-360-1168
Contact Email:	Jeffery.ryan@interscopemed.com
Date Prepared:	December 12, 2019

2. DEVICE NAME

Proprietary Name:	EndoRotor®
Classification Name:	Drill, surgical, ENT (electric or pneumatic) including handpiece
Regulation Name:	Ear, nose, and throat electric or pneumatic surgical drill
Classification Regulation:	21 CFR 874.4250
Product code:	ERL

3. PREDICATE AND REFERENCE DEVICES

Predicate device

Manufacturer:	Medtronic XOMED
Proprietary Name:	XPS 3000 System
Classification Name:	ENT Surgical Drill
510(k) Number:	K041413
Regulation Name:	Ear, nose, and throat electric or pneumatic surgical drill
Classification Regulation:	21 CFR 874.4250
Product Code:	ERL

Reference Device

Manufacturer:	Interscope, Inc.
Proprietary Name:	EndoRotor®
Classification Name:	Endoscopic Morcellator Gastroenterology
510(k) Number:	K181127
Regulation Name:	Hysterscope and accessories
Classification Regulation:	21 CFR 884.1690
Product code:	PTE

4. DEVICE DESCRIPTION

5. INDICATION FOR USE/INTENDED USE

The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

	Subjects	Predicate	Comparison
Sponsor	Interscope, Inc.	Medtronic XOMED
Device name	EndoRotor®	XPS 3000 System
Regulatory
Status	Proposed	K041413
Device
Classification
Code/Name	ENT Surgical Drill	ENT Surgical Drill
Regulation
Number	21CFR 874.4250	21CFR 874.4250
Regulation
Name	Ear, nose and throat electric or
pneumatic surgical drill	Ear, nose and throat electric or
pneumatic surgical drill
Indications for
Use	The EndoRotor® System is
intended for use in airway
procedures including removal
of granulation tissue and
endobronchial lesions.	Nasopharyngeal / laryngeal
indications include
adenoidectomy, tracheal
procedures, laryngeal
polypectomy, laryngeal lesion
debulking, tonsillectomy,
tonsillotomy for obstructive
tonsillar disease, removal of
endobronchial lesions, and the
surgical management of
recurrent respiratory
papillomatosis (RRP).	The indications for use for the
EndoRotor® are limited to
airway procedures, which are a
subset of the predicate
indications.
Components	• Control unit including
peristaltic pump, motor drive
and pinch valve
• Catheter with cutting device
mounted on distal end
• Foot control to control drive
motor
• Specimen trap with pre-
loaded micron filter	• Control unit including
peristaltic pump, motor drive
and
• Handpiece with cutting tool
mounted on distal end
• Foot control to control drive
motor	• The EndoRotor® includes a
specimen trap to collect tissue
samples as needed.
• The EndoRotor® bypasses the
use of a hand piece and rotates
using a multi filar torque cable
attached directly to the
console instead of a hand
piece interface to both the
cutting tool and console.
Resection site
access	Flexible bronchoscope	Rigid bronchoscope	The use of a flexible
bronchoscope allows
EndoRotor® to access distal
sites in the airway. Simulated

Table 1. Side-by-Side Comparison for Determination of Substantial Equivalence

	Subjects	Predicate	Comparison
			use testing of the EndoRotor® in
a test system created based on
the anatomical requirements of
the human lung showed the
EndoRotor® successfully met al
functional requirements.
Principle of
Operation	Mechanical resection using a
rotational cutting cannula with
simultaneous aspiration	Mechanical resection using
rotational movement and
oscillation of the cutting blade
with simultaneous aspiration	Both proposed and predicate
devices use rotational movement
for resection of soft tissue.
Oscillation includes a counter
rotation every third revolution
for use with sinus and bone
resection which is not indicated
for the EndoRotor.
Speed	High: 1000-1750 RPM
Low: 500-1750 RPM	500-5,000 RPM oscillate
500-12,000 RPM forward	The EndoRotor® rotation speeds
are within the operating range o
the predicate. The EndoRotor®
is not indicated for bone
resurfacing functions that
require higher speeds.
Reuse status	Resection cannula: Single use	Resection blade: Single use	Same

Both the proposed EndoRotor® Airway Microdebridement System and the predicate XPS 3000 System are powered resection tools consisting of a power Console, Foot Control, and a single-use cutting tool. The system will be offered with two choices of rotation speeds, either low 500 RPM/high 1000 RPM or low 1000 RPM/high 1750 RPM.

The disposable Catheter supplied for use with the proposed EndoRotor® Airway Microdebridement System includes a debriding cutter and provides aspiration from the site to a Specimen Trap. The cutting tool consists of an outer cylindrical cannula attached to a flexible braided Catheter and a second inner cylindrical cannula positioned inside the lumen of the outer cannula. Microdebridement is achieved through rotational movement of the inner cannula relative to the outer cannula. The Catheter accesses the resection site via a flexible bronchoscope. Simulated use testing confirms that the Catheter functions as designed in a tortuous path.

The EndoRotor® Catheter attaches directly to the Console that provides operational control for the Catheter and includes the drive motor and vacuum control. The Console also houses a peristaltic irrigation pump to provide lavage as needed.

The predicate XPS 3000 System cutting tools used for airway procedures have straight and bent shafts of varying lengths with sharp edges that are mounted in a Handpiece. Microdebridement is achieved via rotational movement of an inner cylindrical cannula positioned inside the lumen of the outer cannula, with an oscillation sequence. The Catheter has a continuously variable oscillation speed of 500-5000 RPM. The mode of operation and speed is set and displayed on the Console. The resection site is accessed via a rigid bronchoscope.

The overall design and operation of the EndoRotor® Airway Microdebridement System are

identical to that of the XPS 3000 System. The EndoRotor® blade design is markedly similar to that of the Tricut blade supplied for use with the predicate device, as well as other sinus debriders. Technical differences between the proposed and predicate debriders are limited to the type of bronchoscope used for accessing the resection site (flexible vs rigid), and the oscillation sequence incorporated into the movement of the predicate cutting tool.

The design and operation of the proposed EndoRotor® Airway Microdebridement System is identical to the EndoRotor® cleared for gastrointestinal use, most recently as K181127 (reference device). The only difference is a decrease in the length of the Catheter supplied for use in airway procedures to accommodate the length of the compatible bronchoscopes vs gastroscopes/colonoscopes. Functional performance testing of the shorter Catheter passed all acceptance criteria.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The EndoRotor® Airway Microdebridement System was verified and validated through a series of physical and mechanical performance tests on the Catheter and Console. These tests are summarized in Table 2.

| EndoRotor®

Component	Testing Performed
EndoRotor® Catheter	• Biocompatibility
• Sterilization validation
• Pyrogenicity
• Shelf-life
• Packaging validation
• Transport testing
• Functional testing*	Met established acceptance criteria
EndoRotor® Console	• Design verification testing
• Power-up and Set-up Testing
• Functional Testing
• Electrical Safety and Electromagnetic
Compatibility Testing	Met established acceptance criteria
Procedural Testing	Specimen Trap: EndoRotor® was evaluated to determine that when proper procedure is
followed as provided in the labeling, including a post procedure flush, there is no residual
specimen in the Catheter.

Table 2. Non-Clinical Performance Testing

*Includes functional performance testing of the EndoRotor® Catheter developed for airway procedures.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical study was conducted to support the 510(k) Premarket Notification. The EndoRotor has been cleared for use in the gastrointestinal system (K181127). The safety and performance of the EndoRotor has been demonstrated for use throughout the alimentary a region where tissue walls less than 2mm. consisting tract. of mucosa/submucosa/muscularis propria, have higher risk to injury with cutting instruments. The evidence supports the clinical performance of EndoRotor for airway debridement.

9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the information summarized above, Interscope concludes that the EndoRotor® Airway Microdebridement System is substantially equivalent to the predicate XPS 3000

System. The bench testing (including simulated use testing to evaluate functional performance for airway procedures), animal testing, and usability testing support the safety and effectiveness of the EndoRotor® Airway Microdebridement System for use in airway procedures.