(176 days)
Not Found
Based on the "overview" you provided, I need to analyze it to determine if the device contains an AI model.
Please provide the "overview" content you are referring to. Once you provide the text, I will be able to analyze the description and tell you whether it mentions or implies the presence of an AI model.
Without the "overview" content, I cannot give you a definitive answer.
No.
The device is used for visualization during surgical procedures, not for treating a condition or disease.
No
The device is used for visualization during surgery, not for diagnosing conditions.
N/A
To determine if the device described in the {{overview}} is an In Vitro Diagnostic (IVD), we need to understand the core definition of an IVD and compare it to the information provided.
What is an IVD?
An IVD is a medical device that is used to perform tests on specimens taken from the human body, such as blood, urine, tissue, or swab samples, outside of the body (in vitro). The purpose of these tests is to provide information about a person's health status, to diagnose or monitor a disease or condition, or to assess the effectiveness of a treatment. Key characteristics of IVDs often include:
- Specimens from the human body: They analyze biological materials taken from a patient.
- Testing "in vitro": The analysis happens outside of the living organism.
- Diagnostic or health information purpose: The results aim to provide insights into health or disease.
- Reagents and equipment: They often involve specific chemical reagents, instruments, and software to perform the analysis.
- Interpretation of results: The device is designed to produce results that are interpreted in a clinical context.
How to determine if the device in the {{overview}} is an IVD:
Based on the {{overview}}, consider the following questions:
- Does the device analyze specimens taken from a human body? (e.g., blood, urine, saliva, tissue, swab sample)
- Does the analysis happen outside of the human body ("in vitro")?
- What is the stated purpose of the device? Does it aim to:
- Diagnose a disease or condition?
- Monitor a disease or condition?
- Predict a risk for a disease?
- Determine compatibility (e.g., blood typing)?
- Assess a physiological or pathological state?
- Assess the effectiveness of a treatment?
- Does the device involve reagents, kits, instruments, or software designed specifically for performing these in vitro tests and interpreting the results?
Conclusion based on the {{overview}}:
Based on the answers to these questions, which can only be obtained by carefully reading the {{overview}}, you can determine if the device falls under the category of an IVD.
- If the {{overview}} clearly describes a device that analyzes human specimens outside the body for a diagnostic or health information purpose, and likely involves reagents or instruments for this analysis, it is highly likely an IVD. You can state your conclusion and the reasons why based on the details in the {{overview}}.
- If the {{overview}} describes a device that interacts with the human body directly (e.g., an implant, a surgical instrument, a device for monitoring vital signs on the body) and does not analyze specimens externally for diagnostic purposes, it is likely not an IVD. You would explain why based on the details in the {{overview}}.
- If the {{overview}} is ambiguous or lacks sufficient detail to definitively determine if it's an IVD, you should state that the information is insufficient to make a definitive determination. You can then list the types of information needed to clarify its classification.
Therefore, PLEASE PROVIDE THE CONTENT OF THE {{overview}} so I can give you a specific and accurate answer.
Once you provide the text of the {{overview}}, I will analyze it and tell you whether the device is likely an IVD and explain my reasoning.
N/A
Intended Use / Indications for Use
The Arthrex Spine Endoscope is indicated for use to provide visualization during spinal endoscopic procedures and minimally invasive surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GCJ
Device Description
The Arthrex Spine Endoscope is a rigid endoscope that contains a rod lens system and optical fibers. When connected to a compatible Arthrex light guide cable and camera system, the endoscope provides image and light transmission, allowing for visualization and illumination of a surgical site. The endoscope includes an ocular funnel, a working channel, inflow and outflow ports, and a connector with adapters for fiber optic light cables. It is available with a 15° or 30° direction of view, outer diameter of 6.3 mm, 7 mm, or 10 mm, and working length of 130 mm, 139 mm, or 181 mm. The Arthrex Spine Endoscope is a reusable multi-patient use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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)
Non-clinical bench testing was developed and performed on the Arthrex Spine Endoscope to confirm the device meets product requirements and device specifications. These include biocompatibility testing, cleaning/disinfection and reprocessing validation, design verification, and electrical, mechanical, and thermal (EMT) safety evaluation. The testing methods used and acceptance criteria are comparable to the predicate device.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
FDA Clearance Letter for Arthrex Spine Endoscope
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 16, 2025
Arthrex, Inc.
Lai Saeteurn
1370 Creekside Blvd.
Naples, Florida 34108
Re: K243602
Trade/Device Name: Arthrex Spine Endoscope
Regulation Number: 21 CFR 888.1100
Regulation Name: Arthroscope
Regulatory Class: Class II
Product Code: HRX, GCJ
Dated: April 16, 2025
Received: April 16, 2025
Dear Lai Saeteurn:
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/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.
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).
Page 2
K243602 - Lai Saeteurn Page 2
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 (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-reporting-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-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-devices/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-advice-comprehensive-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).
Page 3
K243602 - Lai Saeteurn Page 3
Sincerely,
JESSE MUIR -S
Digitally signed by JESSE MUIR -S
Date: 2025.05.16 10:30:22 -04'00'
Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative, Repair
and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
Device Name
Arthrex Spine Endoscope
Indications for Use (Describe)
The Arthrex Spine Endoscope is indicated for use to provide visualization during spinal endoscopic procedures and minimally invasive surgery.
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.
Page 5
510(k) Summary
Date Prepared | May 14, 2025
Submitter | Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
Contact Person | Name: Lai Saeteurn
Phone: 239-643-5553
Email: Lai.Saeteurn@Arthrex.com
Trade Name | Arthrex Spine Endoscope
Classification Name | 21 CFR 888.1100: Arthroscope
21 CFR 876.1500: Endoscope and accessories
Product Code | HRX, GCJ
Common Name | Spinal Endoscope
Regulatory Class | Class II
Primary Predicate Device | K130778 RZ Medizintechnik Cervical Endoscopes
Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Spine Endoscope.
Device Description | The Arthrex Spine Endoscope is a rigid endoscope that contains a rod lens system and optical fibers. When connected to a compatible Arthrex light guide cable and camera system, the endoscope provides image and light transmission, allowing for visualization and illumination of a surgical site. The endoscope includes an ocular funnel, a working channel, inflow and outflow ports, and a connector with adapters for fiber optic light cables. It is available with a 15° or 30° direction of view, outer diameter of 6.3 mm, 7 mm, or 10 mm, and working length of 130 mm, 139 mm, or 181 mm. The Arthrex Spine Endoscope is a reusable multi-patient use device.
Indications for Use | The Arthrex Spine Endoscope is indicated for use to provide visualization during spinal endoscopic procedures and minimally invasive surgery.
Performance Data | Non-clinical bench testing was developed and performed on the Arthrex Spine Endoscope to confirm the device meets product requirements and device specifications. These include biocompatibility testing, cleaning/disinfection and reprocessing validation, design verification, and electrical, mechanical, and thermal (EMT) safety evaluation. The testing methods used and acceptance criteria are comparable to the predicate device.
Technological Comparison | The Arthrex Spine Endoscope and predicate device have the same intended use, indications for use, and technological characteristics (i.e., design, materials, principle of operation, manufacturing and packaging processes, cleaning, disinfection and reprocessing requirements).
Conclusion | All verification activities were successfully completed to confirm the subject device meets product requirements and design specifications established for the device.
Page 6
Page 2 of 2
The Arthrex Spine Endoscope did not require animal testing or human clinical studies to support the determination of substantial equivalence.
Based on the same intended use, indications for use, technological characteristics, and successful completion of non-clinical bench testing, the Arthrex Spine Endoscope is as safe and as effective as the legally marketed predicate device. Any differences between the subject device and predicate device are considered minor and do not raise different questions concerning safety and effectiveness.