(105 days)
Not Found
No
The description focuses on mechanical and electrical functions for surgical procedures and does not mention any AI or ML components or capabilities.
No.
The device is a surgical instrument used to cut, grasp, dissect, and coagulate tissue during surgical procedures, which are considered interventions rather than therapeutic actions in themselves.
No
Explanation: The device is described as a surgical tool used for cutting, grasping, dissecting, and coagulating tissue during endoscopic/laparoscopic procedures. It is an instrument for intervention, not for diagnosis.
No
The device is a physical surgical handpiece with multiple components and variations, designed for cutting, grasping, dissecting, and coagulating tissue during endoscopic procedures. It is a hardware device.
Based on the provided information, the ReNew XR Handpiece is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures." This describes a surgical instrument used directly on tissue within the body.
- Device Description: The description details a reusable laparoscopic surgical device that works in combination with other surgical tools and an electrosurgical generator. It is used for physical manipulation and energy delivery to tissue during surgery.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The ReNew XR Handpiece does not perform any such analysis of specimens.
The device is clearly described as a surgical instrument used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ReNew XR Handpiece is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, and dissectors (all of which are outside of the scope of this submission), to cut, grasp, and dissect various tissues for use in endoscopic, including laparoscopic, surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece does not produce energy, but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a hand-held active electrode and travels back to the electrosurgical generator through a return electrode attached to the patient, so that the patient is part of the electrical circuit. The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.
The subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.
Variations of the subject devices include varying handle length, presence of a ratcheting mechanism, and single-piece vs. modular (three piece) instruments. Details of the composition of each model number are shown in Table 5.1 below.
The predicate device ReNew Laparoscopic Handpiece [510(k) submission also included end effectors used with the handpiece. These end effectors are not the subject of the current 510(k) and continue to be legally marketed under the existing FDA clearance. Performance testing of the handpiece (see Section 18 (Performance Testing - Bench) and Section 19 (Performance Testing - Animal)) includes use of appropriate end effectors.
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 non-sterile and intended for cleaning and sterilization by a medical facility before use.
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 as design verification testing and to establish Substantial Equivalence to the predicate device. The functional testing for the subject devices primarily included nonclinical (ex vivo and animal) testing, electrical safety testing, cleaning and sterilization, and biocompatibility testing. The testing establishes that subject device is Substantially Equivalent to the predicate device in fundamental technology, design, or performance. There were no new risks or safety, or effectiveness issues raised in the testing results.
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 process", [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 specific considerations for the following testing:
o Cytotoxicity as recommended per ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;
o Intracutaneous Reactivity, as recommended per ISO 10993-10, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization;
o Delayed type Sensitivity, as recommended per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
o Acute Systemic Toxicity testing, as recommended per ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity; and
o Pyrogenicity, as recommended per ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity, to address the risks evaluation associated with the presence of bacterial endotoxins.
o Sample Preparation, as outlined in the ISO 10993-12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, was employed for the sample preparation using surface area to extract volume ratios.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 agency's name, "U.S. Food & Drug Administration."
October 21, 2020
Microline Surgical, Inc. Scott Marchand Davis Director, RA/OA 50 Dunham Road, Suite 1500 Beverly, Massachusetts 01915
Re: K201884
Trade/Device Name: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 18, 2020 Received: September 21, 2020
Dear Scott Marchand 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 (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.
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 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 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, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201884
Device Name ReNew XR Handpiece
Indications for Use (Describe)
The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.
Type of Use (Select one or both, as applicable)
|--|--|
X | 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
5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Scott Marchand Davis
Director, RA/QA
Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915 USA
Telephone: 978-922-9810
Fax: 978-922-9209
smarchanddavis@microlinesurgical.com |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott Marchand Davis
Director, RA/QA
Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915 USA
Telephone: 978-922-9810
Fax: 978-922-9209
smarchanddavis@microlinesurgical.com |
| Date Summary Prepared: | July 6, 2020 |
5.2 Name of the Device
| Trade Name: | ReNew XR Handpiece |
|---|---|
| Common Name: | Manual Detachable Surgical Instruments |
| Classification Name: | General & Plastic Surgery |
| Review Panel: | General & Plastic Surgery (SU) |
| Regulation: | 878.4400 |
| Class: | Class II |
| Product Code: | GEI |
5.3 Substantial Equivalence Claimed to Predicate Device
The ReNew XR Handpiece is substantially equivalent to the RE-NEW LAPAROSCOPIC INSTRUMENTS (K962119), manufactured by MICROLINE PENTAX, INC.
5.4 DEVICE DESCRIPTION
4
K201884
The ReNew XR Handpiece is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, and dissectors (all of which are outside of the scope of this submission), to cut, grasp, and dissect various tissues for use in endoscopic, including laparoscopic, surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece does not produce energy, but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a hand-held active electrode and travels back to the electrosurgical generator through a return electrode attached to the patient, so that the patient is part of the electrical circuit. The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.
The subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.
Variations of the subject devices include varying handle length, presence of a ratcheting mechanism, and single-piece vs. modular (three piece) instruments. Details of the composition of each model number are shown in Table 5.1 below.
The predicate device ReNew Laparoscopic Handpiece [510(k) submission also included end effectors used with the handpiece. These end effectors are not the subject of the current 510(k) and continue to be legally marketed under the existing FDA clearance. Performance testing of the handpiece (see Section 18 (Performance Testing - Bench) and Section 19 (Performance Testing - Animal)) includes use of appropriate end effectors.
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.
| Model Number | Description |
|---|---|
| 3941 | 34cm length, non-ratcheted, one-piece |
| 3942 | 42cm length, non-ratcheted, one-piece |
| 3943 | 25cm length, non-ratcheted, one-piece |
| 3944 | 34cm length, ratcheted, one-piece |
| 3945 | 42cm length, ratcheted, one-piece |
| 3946 | 25cm length, ratcheted, one-piece |
| 3530 | 34cm length, non-ratcheted, modular three-piece |
The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.
5
| 3531 | 42cm length, non-ratcheted, modular three-piece |
|---|---|
| 3532 | 34cm length, ratcheted, modular three-piece |
| 3533 | 42cm length, ratcheted, modular three-piece |
5.5 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Like the predicate device, the subject device is composed of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly. The subject device is virtually identical to the predicate in terms of indication for use and operation, and is substantially equivalent in design, technological characteristics, materials, and labeling .
The most significant differences between the predicate device and the subject are the following:
-
The seal between the handpiece tip and the accessory tips has been changed from an elastomer o-ring to a solid overmolded polyvinylidene fluoride bushing to improve service life.
-
The internal metal components of the overmolded variable and fixed handles have been changed to improve insulation to the ratchet and hand grip areas during electrosurgery.
-
The color of the top cover and rotation knob has been changed from black to grey.
Both the subject devices and predicate devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.
5.6 INDICATIONS FOR USE
The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures. Contraindications: None known.
5.7 PERFORMANCE DATA
The subject device's performance characteristic testing requirements were assessed in accordance to the requirements set forth in 21 CFR § 820 for Quality System Regulation (OSR), under the FD&C Act, including current Good Manufacturing Practices (cGMP) requirements under this regulation and Microline Surgical, Inc. (hereafter referred to as MSI or Microline) internal procedures documented and applicable within the Corporate Quality System and Product Development procedures.
Bench performance testing was performed as design verification testing and to establish Substantial Equivalence to the predicate device. The functional testing for the subject devices primarily included nonclinical (ex vivo and animal) testing, electrical safety testing, cleaning and sterilization, and biocompatibility testing. The testing establishes that subject device is Substantially Equivalent to the predicate device in fundamental technology, design, or performance. There were no new risks or safety, or effectiveness issues raised in the testing results. The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.
Biocompatibility Testing:
6
K201884
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 process", [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 specific considerations for the following testing:
o Cytotoxicity as recommended per ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity;
o Intracutaneous Reactivity, as recommended per ISO 10993-10, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization;
o Delayed type Sensitivity, as recommended per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
o Acute Systemic Toxicity testing, as recommended per ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity; and
o Pyrogenicity, as recommended per ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity, to address the risks evaluation associated with the presence of bacterial endotoxins.
o Sample Preparation, as outlined in the ISO 10993-12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, was employed for the sample preparation using surface area to extract volume ratios.
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.
5.8 SUBSTANTIAL EQUIVALENCE CONCLUSION
Based upon the similarities in materials of construction, device design, performance, fundamental technology and the intended use/indications for use, including assessments of the proposed modifications to the subject devices, the subject devices are deemed Substantially Equivalent to their legally marketed predicate device, ReNew Laparoscopic Handpiece [510(k): K962119). Liketheir predicate device, the subject devices are Class II devices per 21 CFR § 878.4400, Subpart E, Product Code GEI, which under this classification category is identified as Electrosurgical Cutting and Coagulation devices and accessories.
SUBSTANTIAL EQUIVALANCE STATEMENT:
The subject devices do not raise new questions of safety and effectiveness, and have been demonstrated to be at least as safe and effective as their legally marketed predicate device ReNew Laparoscopic Handpiece [510(k): K962119].