Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and electrical properties, with no mention of AI/ML algorithms or data processing.

Therapeutic

Yes.
The device is used for "cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures," which are therapeutic interventions.

Diagnostic

No

Explanation: The device, ReNew single patient use disposable scissor tips, is described for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures. Its function is to perform a surgical action (cutting and coagulation), not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical surgical instrument (scissor tips) with multiple hardware components and undergoes bench and animal testing for physical performance and safety. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures." This describes a surgical tool used directly on the patient's tissue in vivo.
Device Description: The description details the physical components of a surgical scissor tip designed for use with a laparoscopic handpiece.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples outside the body. This device is used inside the body during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.

This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.

The subject devices are made of ten (10) primary components which includes the following:

Front Hub ●
Overmolded Back Hub ●
Disc Spring ●
Yoke
Yoke Pin ●
Crimp Pin
Short Blade
Long Blade ●
Surgislip Lubricant ●
Heat Shrink with Adhesive Polymer

There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.

The subject devices are supplied as sterile. In accordance to 21 CFR § 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Bench performance testing was performed on the subject devices to establish that the subject devices meet the performance specifications criteria to determine Substantial Equivalence with their legally marketed predicate device. In accordance with design controls, the design verification testing was performed for the subject devices. The functional testing for the subject devices primarily included:

Cutting equivalency to the currently marketed device
Assembly and disassembly to the ReNew Handpiece ●
Heat-shrink printing adhesion ●
Tissue thermal spread ●
Ethylene Oxide (EO) Sterilization Validation
Electrical Safety and EMC testing per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 ●

Biocompatibility testing successfully established that the subject devices did not raise any new risks, and that they were determined to be biologically safe.

Animal testing was performed to test the coagulation performance of the ReNew disposable tips with overmolded Radel backhubs and redesigned ReNew handpieces. The study was conducted in compliance with the Food and Drug Administration Good Laboratory Practice Regulations.

The nonclinical (animal) testing demonstrated that the subject devices met all the design and predetermined performance specifications to demonstrate their intended use.

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.

K962119

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.

K201884

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

March 2, 2022

Microline Surgical, Inc. Scott Davis Director, QA/RA 50 Dunham Road. Suite 1500 Beverly, Massachusetts 01915

Re: K213127

Trade/Device Name: ReNew Disposable Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2022 Received: January 26, 2022

Dear Scott Davis:

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 ffor 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/cfpm/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 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 (0S) 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, PhD 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

2

Indications for Use

510(k) Number (if known) K213127

Device Name

ReNew Laparoscopic Instruments Disposable Scissor Tips

Indications for Use (Describe) Indications for Use:

The ReNew single patient use disposable scissor tips are to be used with the ReNew

Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

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) ☐

|| | Prescription Use (Part 21 CFR 801 Subpart D)

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Traditional 510(k) Summary

[As Required by 21 CFR § 807.92]

I. SUBMITTER:

Applicant:	Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly, MA 01915 USA
Establishment Registration Number:	1223422
Contact Representative:	Mr. Scott Marchand Davis Director, QA/RA Microline Surgical, Inc. Phone: 978-867-1758/Fax: 978-922-9209 Email: smarchanddavis@microlinesurgical.com
Date Prepared:	February 22, 2022

II. DEVICE:

Device Trade or Proprietary Name:	ReNew Laparoscopic Instruments Disposable Scissor Tips
Common Name:	Manual Detachable Surgical Instruments
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation:	21 CFR § 878.4400
Classification:	Class II
Regulation Medical Specialty:	GEI
510(k) Review Panel:	General and Plastic Surgery.
Accessories for Subject Device:	None. [This submission is for the Disposable Scissor Tips; the ReNew Handpiece, to which it attaches, is the subject of a separate 510(k) clearance]

III. PREDICATE DEVICE:

III. PREDICATE DEVICE:

Predicate Device:

4

"Re-New" Laparoscopic Instruments [510(k): K962119]

IV. DEVICE DESCRIPTION:

This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.

This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.

The subject devices are made of ten (10) primary components which includes the following:

Front Hub ●
Overmolded Back Hub ●
Disc Spring ●
Yoke
Yoke Pin ●
Crimp Pin
Short Blade
Long Blade ●
Surgislip Lubricant ●
Heat Shrink with Adhesive Polymer

There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.

The subject devices are supplied as sterile. In accordance to 21 CFR $ 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.

V. INDICATIONS FOR USE:

Device Name:

ReNew Laparoscopic Instruments Disposable Scissor Tips

Indications for Use:

5

The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Contraindications:

The ReNew single patient use disposable scissor tips are not intended for use except as indicated.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Overall, the subject devices, in comparison to their predicate device, are similar in the fundamental technology, intended use, and materials used in the method of construction. The primary differences between the predicate device and the subject include the following:

Change from two-piece hub assembly to one-piece overmolded hub 1.
1. Minor change to heat-shrink tubing to include an adhesive layer

To provide further detail, the current ReNew Disposable Scissor Hub Assembly requires that hub assemblies be created by screwing the front hub to the back hub and adding epoxy before they can be used on the automated assembly line. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub, which is done by an outside vendor. This eliminates the labor required of Microline employees to create the hub assembly. The new overmolded hub assembly does not have a threaded joint or epoxy. The updated front hub has a crisscross pattern that the back hub is overmolded on to. The predicate device back hub is made from PEEK and the subject device back hub is made from Radel. All appropriate testing has been performed on the Radel back hubs to ensure they meet requirements.

Due to the change to the hub design, an additional change needed to be made to the heat shrink on the scissor tip. The current heat shrink, MT5000, is made from polyolefin tubing. The updated heat shrink, MT5000A, is the same base material and has an inner polymer lining made of ELVAX 760, an ethylene vinyl acetate copolymer. The polymer layer acts as an adhesive for heat shrink. It melts as the polyolefin tubing shrinks, providing a seal to insulate and prevent passage of moisture.

| Characteristics | Predicate Device
[510(k): K962119] | Subject Device
[510(k): K213127] |
|-----------------------------|---------------------------------------------------------|--------------------------------------------------------------|
| Trade or Proprietary Name | "Re-New" Laparoscopic
Instruments | ReNew Laparoscopic
Instruments Disposable Scissor
Tips |
| 510(k) Number | K962119 | K213127 |
| 510(k) Clearance Date | August 9th, 1996 | Not Applicable |
| Classification | Class II
21 CFR § 878.4400 | Class II
21 CFR § 878.4400 |
| Classification Name | Electrosurgical, Cutting &
Coagulation & Accessories | Electrosurgical, Cutting &
Coagulation & Accessories |
| Classification Product Code | GEI | GEI |

The following table shows a comparison of the subject and predicate devices:

6

| Common Name | Manual Detachable Surgical
Instruments | Manual Detachable Surgical
Instruments |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Marketed Brand Name | ReNew Disposable Scissor Tips | ReNew Disposable Scissor Tips |
| Regulation Medical
Specialty | General and Plastic Surgery | General and Plastic Surgery |
| Environment of Use | Hospital, Operating Room (OR) | Hospital, Operating Room (OR) |
| Intended Use | Indications for Use Statement:
Endoscopic (inclusive of
laparoscopic) Surgical Procedures | Indications for Use
Statement:
The ReNew single patient use
disposable scissor tips are to be
used with the ReNew
Laparoscopic Hand Pieces and
they are indicated for cutting
and coagulation of tissue in
endoscopic and laparoscopic
surgical procedures. |
| | Contraindications:
None listed | Contraindications:
The ReNew single patient use
disposable scissor tips are not
intended for use except
as indicated.

7

8

9

In comparison to their predicate device, the subject devices are identical in fundamental technology and intended use. The subject devices are supplied as sterile.

VII. PERFORMANCE DATA:

The subject device's performance characteristic testing requrements were assessed in accordance with the requirements set forth in 21 CFR § 820 for Quality System Regulation (QSR), under the FD&C Act, including current Good Manufacturing Practices (cGMP) requirements under this regulation and Microline Surgical, Inc. (hereafter referred to as MSI) internal procedures documented and applicable within the Corporate Quality System and Product Development procedures.

Bench performance testing was performed on the subject devices to establish that the subject devices meet the performance specifications criteria to determine Substantial Equivalence with their legally marketed predicate device. In accordance with design controls, the design verification testing was performed for the subject devices. The functional testing for the subject devices primarily included:

Cutting equivalency to the currently marketed device
Assembly and disassembly to the ReNew Handpiece ●
Heat-shrink printing adhesion ●
Tissue thermal spread ●
Ethylene Oxide (EO) Sterilization Validation
Electrical Safety and EMC testing per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 ●

Fundamentally, the subject device is Substantially Equivalent in fundamental technology and identical in intended use to its legally marketed predicate device. There were no new risks or safety, or effectiveness issues raised in the bench testing results. The subject devices are supplied as sterile.

Biocompatibility Testing:

Pursuant to ISO 10993-1:2009/AC: 2010 - Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process; 21 § CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies; and FDA's Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management trovess", [issued on: June 16, 2016], which includes the FDA-modified matrix designating the type of testing for biological evaluation, the biological assessment of the subject devices was conducted.

The biological evaluation testing matrix included the following testing:

Cytotoxicity (ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity);
Intracutaneous Reactivity, as recommended per, ISO 10993-10, Biologial waluation of medical O devices - Part 10: Tests for irritation and skin sensitization);

10

Delayed type Sensitivity, as recommended per, ISO 10993-10, Biological evaluation of medical o devices - Part 10: Tests for irritation and skin sensitization); and
Acute Systemic Toxicity testing, as recommended per ISO 10993-11, Biological evaluation of O medical devices - Part 11: Tests for systemic toxicity).
Pyrogenicity, as recommended per ISO 10993-11, Biological evaluation of medical devies Part 11: O Tests for systemic toxiity), to address the risks associated with the presence of chemical pyrogens in the material.

For the subject devices, biocompatibility testing successfully established that the subject devices did not raise any new risks, and that they were determined to be biologically safe.

Performance Testing - Animal:

Animal testing was performed to test the coagulation performance of the ReNew disposable tips with overmolded Radel backhubs and redesigned ReNew handpieces. The study was conducted in compliance with the Food and Drug Administration Good Laboratory Practice Regulations.

The nonclinical (animal) testing demonstrated that the subject devices met all the design and predetermined performance specifications to demonstrate their intended use.

VIII. SUBSTANTIAL EQUIVALANCE CONCLUSION:

Based upon the similarities in materials of construction, device design, performance, fundamental technology and the intended use, including the modifications to the design applicable to the subject devices, MSI has determined that the subject devices are deemed Substantially Equivalent to their legally marketed predicate device, "Re-New" Laparoscopic Instruments [510(k): K962119]. Similar to their predicate device, the subject devices are Class II devices per 21 CFR $ 878.4400, Product Code GEI, which under this classification category is identified as Electrosurgical, Cutting & Coagulation & Accessories. The predicate 510(k), K962119, was originally submitted for both the disposable scissor tips and the ReNew Handpiece. This new submission is solely for the disposable scissor tips. The ReNew Handpiece has been updated and cleared recently in submission K201884.

SUBSTANTIAL EQUIVALANCE STATEMENT:

The subject device does not raise new questions of safety and effectiveness and testing and evaluation demonstrates that it is at least as safe and effective as the legally marketed predicate, "Re-New" Laparoscopic Instruments [510(k): K962119].