(116 days)
The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.
The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.
The ReNew XR Handpiece with Reference Markings is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this submission). It is indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic procedures and it is also indicated for reference length measurement of tissue during endoscopic surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece with Reference Markings is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece with Reference Markings 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 with Reference Markings delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a handheld active electrosurgical generator through a return electrode attached to the patient is part of the electrical circuit. The Relew XR Handpiece with Reference Markings can be used with a legally marketed third party electro-surgical 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.
Like the predicate device, 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 and presence of a ratcheting mechanism.
The provided text describes a 510(k) premarket notification for electrosurgical handpieces. It outlines the device, its intended use, and comparisons to a predicate device. However, it does not contain the specific information required to answer your questions about acceptance criteria for an AI/ML powered device, its performance against those criteria, or details regarding study design for evaluating such a device.
The product in question, the "ReNew XR Handpiece," is a mechanical surgical instrument, not an AI/ML powered device. The document focuses on regulatory compliance for a medical device that facilitates laparoscopic surgeries, including reference length measurement.
Therefore, I cannot extract the information you requested about acceptance criteria, study details, and ground truth for an AI/ML powered device from the provided text.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2024
Microline Surgical, Inc. Scott Marchand Davis Director, QA/RA 50 Dunham Road, Suite 1500 Beverly, Massachusetts 01915
Re: K234147
Trade/Device Name: ReNew XR Handpiece, 25cm, with Bariatric Markings (3943M); ReNew XR Handpiece. 34cm, with Bariatric Markings (3941M); ReNew XR Handpiece, 42cm, with Bariatric Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Bariatric Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Bariatric Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Bariatric Markings (3945M) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 11, 2024 Received: March 27, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
| Mark-S | Digitally signedby MarkTrumbore -SDate: 2024.04.2313:01:50 -04'00' |
|---|---|
| Trumbore |
Mark Trumbore, Ph.D. Assistant Director
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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
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K234147
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Device Name ReNew XR Handpiece, 25cm, with Reference Markings (3943M): ReNew XR Handpiece, 34cm, with Reference Markings (3941M): ReNew XR Handpiece, 42cm, with Reference Markings (3942M): ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) Indications for Use (Describe) The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.
The ReNew XR Handpiece is also indicated for reference length measurement of tissue during 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)
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| K234147 | Page 1 of 3 | |
|---|---|---|
| 510(k) Summary | Prepared on: 2024-04-22 |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Microline Surgical, Inc. |
| Applicant Address | 50 Dunham Rd, Suite 1500 Beverly MA 01915 United States |
| Applicant Contact Telephone | (978)922-9810 |
| Applicant Contact | Mr. Scott Marchand Davis |
| Applicant Contact Email | smarchanddavis@microlinesurgical.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number | 878.4400 |
| Product Code | GEI |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K201884 | ReNew XR Handpiece | GEI |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The ReNew XR Handpiece with Reference Markings is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this submission). It isend effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this s indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic procedures and it is also indicated for reference length measurement of tissue during endoscopic surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece with Reference Markings is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece with Reference Markings does not produce energy but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such
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a generator, the ReNew XR Handpiece with Reference Markings delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a handheld active electrosurgical generator through a return electrode attached to the patient is part of the electrical circuit. The Relew XR Handpiece with Reference Markings can be used with a legally marketed third party electro-surgical 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.
Like the predicate device, 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 and presence of a ratcheting mechanism. Details of the composition of each model number are shown in the table below.
The predicate device, ReNew XR Handpiece [510(k); and the subject device both require end effectors for use. The 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 includes use of appropriate end effectors.
There are no medicinal substances associated with the subject devices. There is manufacturing of the subject devices, and they are not made with Natural Rubber Latex, BisphenolA, Vinyl (PVC) or Phthalates.
The subject devices are supplied as non-sterile and intended to be cleaned and sterilized by a medical facility before use.
Table: Description of Product Variants
Model Number Description
- 3943M 25cm length, non-ratcheted, one-piece
- 3941M 34cm length, non-ratcheted, one-piece
3942M 42cm length, non-ratcheted, one-piece
- 3946M 25cm length, ratcheted, one-piece
- 3944M 34cm length, ratcheted, one-piece
- 3945M 42cm length, ratcheted, one-piece
Intended Use/Indications for Use
The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.
The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.
Indications for Use Comparison
The ReNew XR Handpiece with Reference Markings and the ReNew XR Handpiece have intended use as both devices are to be used during laparoscopic surgeries, however, the indications have changed to add a reference measurement to the ReNew XR with Reference Markings. These measurements help to facilitate laparoscopic surgeries, where a rough estimate of tissue size is helpful in facilitating the procedure.
Technological Comparison
The technological characteristics, principle of operation, and material of the ReNew XR Handpiece with Reference Markings and the ReNew XR Handpiece are nearly identical. Both 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. The main difference is the ReNew XR Handpiece with Reference Markings has the addition of lines and markings printed on the handpiece shaft to be used for reference length measurements. The ink that is used for the same ink that is currently used on the ReNew XR Handpiece device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Cleaning and sterilization testing for the reusable ReNew XR Handpiece was conducted per ANSI/AAM//SO 176651: 2006, Sterilization of health care products – Moist heat Requirement, validation and routine control of sterilization process for medical devices and AAM TR30:2011. Detailed instructions and parameters for cleaning and sterilization are provided in the instructions for use. Complete details on the cleaning and sterilization testing, as well as associated shelf life and use life testing, are provided in the Reprocessing, Sterility, and Shelf-Life section (PD102-171R, PD102-172R, and PD102-244R).
Blocompatibility testing was performed per ISO 109931:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process. The devices were considered blood/pody fluid/tissue contact devices. Complete
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
K234147
Page 2 of 3
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details on biocompatibility testing are provided in the Biocompatibility section (PD102-243R).
Electromagnetic compatibility and electing was conducted per ISO 60601 Medical Electrical Eguipment, using a legally marketed electrosurgical generator as an energy source. Complete details on electromagnetic compatibility testing are provided in the EMC, Wireless, Electrical, Mechanical, and Thermal Safety section (PD60-168R)
Bench performance testing of the device included mechanical strength testing for cleaning, trocar compatibility, insufflation testing, impact resistance testing of thermal spread during electrocoagulation. Complete details on bench performance testing are provided in the Performance section; Bench Tests (PD102-179R, PD102-168R, PD102-096R, PD102-097R, PD60-160R, PD102-167R, and PD102-168R)
There is no clinical (human) performance data concluded, existing, or acquired for the ReNew XR Handpieces with Reference Markings to evaluate its clinical performance.
Based on the minimal design changes and the testing performed (PD102-239R; Animal Lab Report), the subject device is as safe as the predicate device, as effective at cutting, dissecting, grasping, and effective at reference measurement.
§ 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.