(28 days)
Not Found
No
The summary describes a mechanical sizing tool with numerical indicators and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as a "laparoscopic accessory used to estimate the appropriate size LINX® device," indicating it's a tool for sizing, not a treatment itself. It's an accessory to a management system, not the therapeutic device itself.
No
This device is described as an "Esophagus Sizing Tool" used to "estimate the appropriate size LINX® device." Its function is to measure for sizing, not to diagnose a medical condition or disease.
No
The device description explicitly states it is a "sterile, single-use device" with a "soft, circular curved tip" actuated by "coaxial tubes via a handset," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "estimate the appropriate size LINX® device" for the LINX Reflux Management System. This is a tool used during a surgical procedure to help select the correct size of an implantable device.
- Device Description: The description details a physical tool with a tip and handset used for measurement in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are typically used to diagnose, monitor, or screen for diseases or conditions by examining samples outside the body.
Therefore, the ETHICON LINX® Esophagus Sizing Tool is a surgical accessory used for measurement during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.
Product codes (comma separated list FDA assigned to the subject device)
QJN
Device Description
The LINX Esophagus Sizing Tool is a sterile, single-use device that is used as an accessory to the LINX Reflux Management System (packaged separately). The device has a soft, circular curved tip that is actuated by coaxial tubes via a handset. The handset contains numerical indicators that correspond to the size range of the LINX implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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)
No laboratory evaluations or bench testing were conducted to demonstrate that the LINX Esophagus Sizing Tool is equivalent to the predicate.
No bench tests were performed to support substantial equivalence to the predicate.
No animal tests were performed to demonstrate substantial equivalence to the predicate.
This premarket notification does not rely on human clinical data to demonstrate substantial equivalence.
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.
ETHICON LINX® Esophagus Sizing Tool K201035
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
§ 876.5360 Laparoscopic gastrointestinal sizing tool.
(a)
Identification. A laparoscopic gastrointestinal sizing tool is a prescription use device intended for laparoscopically measuring an extraluminal dimensional parameter of the indicated gastrointestinal organs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:
(i) Trocar compatibility, which includes shaft bending force characterization;
(ii) Joint strength tensile testing;
(iii) Distal loop extension/retraction force characterization;
(iv) Material selection analysis, which includes corrosion and visual inspection; and
(v) Accuracy of the dimensional measurement.
(2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Labeling of the device must include the following:
(i) A statement regarding metal allergies if the device is made from metallic components;
(ii) Specific instructions for proper device use including information regarding the following:
(A) Inspection of device prior to use;
(B) Surgical access techniques or methodologies;
(C) Instructions for avoiding structural damage to vagus nerve bundle;
(D) Trocar compatibility;
(E) Sizing methodology; and
(F) Minimum and maximum dimensional parameters that the device is capable of measuring.
(iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and
(iv) An expiration date.
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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
February 9, 2023
Torax Medical Inc. Brian Godwin Associate Director, Regulatory Affairs 4188 Lexington Avenue North Shoreview, MN 55126
Re: K230089
Trade/Device Name: ETHICON LINX® Esophagus Sizing Tool Regulation Number: 21 CFR 876.5360 Regulation Name: Laparoscopic gastrointestinal sizing tool Regulatory Class: Class II Product Code: QJN Dated: January 11, 2023 Received: January 12, 2023
Dear Brian Godwin:
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
1
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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K230089
Device Name ETHICON LINX® Esophagus Sizing Tool
Indications for Use (Describe)
The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.
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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510(k) Summary
| Submitter Information: | Torax Medical Inc.
4188 Lexington Avenue North
Shoreview, MN 55126 |
|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Brian Godwin
Associate Director, Regulatory Affairs
Torax Medical Inc.
Telephone: (513) 337-3623
Email: bgodwin@its.jnj.com |
| Date Prepared: | 10 January 2023 |
| Device Trade Name: | ETHICON LINX® Esophagus Sizing Tool |
| Device Common Name:
Classification Regulation:
Device Class:
Panel:
Classification (Product) Code: | Laparoscopic gastrointestinal sizing tool
21 CFR 876.5360
II
78, Gastroenterology and Urology
QJN |
| Predicate Device: | ETHICON LINX® Esophagus Sizing Tool
K201035, cleared 09 July 2020 |
Device Description
The LINX Esophagus Sizing Tool is a sterile, single-use device that is used as an accessory to the LINX Reflux Management System (packaged separately). The device has a soft, circular curved tip that is actuated by coaxial tubes via a handset. The handset contains numerical indicators that correspond to the size range of the LINX implant.
Indications for Use
The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.
Technological Characteristics
The design and performance of the LINX Esophagus Sizing Tool is based on the currently marketed predicate device. The changes described in this submission do not affect the intended use of the device or alter the fundamental scientific technology of the device. The clinical, technical, and biological parameters of the subject device are the predicate. The technique used for determining the appropriate LINX implant device size remains unchanged between the subject and predicate; however, the Instructions for Use have been updated for clarity on implanting based on current clinical practice, reflected in the edits below.
-
- Retract the distal white loop until the loop rests comfortably around the esophagus but does not compress the esophagus and can move with shaft rotation. Note the
4
number indicated by the numerical markings on the handset. This gives the approximate size of the esophagus in "bead-size."
-
- Using the readout provided in Step 8 and considering anatomic and physiological considerations, choose the implant size that best suits the patient's unique clinical scenario. When a readout is between sizes, it is recommended to use the larger of the sizes.
The subject and predicate devices are both manually powered and not powered by an outside energy source. Neither the subject device nor predicate device uses software.
- Using the readout provided in Step 8 and considering anatomic and physiological considerations, choose the implant size that best suits the patient's unique clinical scenario. When a readout is between sizes, it is recommended to use the larger of the sizes.
Performance Data
No laboratory evaluations or bench testing were conducted to demonstrate that the LINX Esophagus Sizing Tool is equivalent to the predicate.
Sterilization & Shelf Life
There have been no changes to the sterilization parameters or shelf life of the LINX Esophagus Sizing Tool.
Biocompatibility & Pyrogenicity
There have been no changes to the materials used in the LINX Esophagus Sizing Tool.
Bench Testing
No bench tests were performed to support substantial equivalence to the predicate.
Animal Testing
No animal tests were performed to demonstrate substantial equivalence to the predicate.
Clinical Studies
This premarket notification does not rely on human clinical data to demonstrate substantial equivalence.
Conclusion
The risk profile of the subject device has not changed as a result of the described changes while having the same intended use as the predicate device; furthermore, the performance of the subject device is consistent with the predicate device and does not raise any new questions of safety and effectiveness.