(272 days)
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.
The provided text is a 510(k) summary for a medical device called "EDEN ControlCath." This document details the device's characteristics, intended use, and its comparison to a predicate device to demonstrate substantial equivalence.
However, the provided text DOES NOT contain information regarding:
- Acceptance criteria beyond "test criteria" for various bench tests.
- Specific device performance metrics that meet these criteria.
- Study design for proving acceptance criteria, particularly regarding clinical studies or AI model performance. The document explicitly states, "Clinical testing was not required for this submission."
- Sample sizes used for test or training sets for AI models.
- Data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established, as these are typically relevant for AI/ML-based medical devices or diagnostics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate conventional medical device through bench testing and material comparisons, not an AI/ML device.
To answer your request based on the provided text, I can only state the following:
1. A table of acceptance criteria and the reported device performance:
The document mentions that various properties were tested based on referenced standards, and "All the test results support substantial equivalence to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "tensile strength > X N") or measured device performance values. It broadly states that the device "passed the test criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Properties (Bench Tests) | The device "passed the test criteria for the side-by-side test" for Diameter and Catheter Length. |
| Key Performance Specification/Characteristics | The device's performance for "Catheter: Tensile Load, Liquid Leakage, Corrosion Resistance, Fatigue, Flexural Strength"; "Trocar: Outer and Inner Surface, Flexural Strength, Pull Out, Elasticity, Pierce"; "Sheath: Tensile Load, Flexural Strength"; and "Guide Wire: Strength" is "Same as predicate device(*)" and passed relevant tests. |
| Raw Materials (Biocompatibility) | The device "passed the test criteria for the bench test according to the recognized consensus standard (ISO 10993-1 Series)." All directly/indirectly contacting materials are "compliant with ISO10993 requirements." |
| Sterilization | The device "passed the test criteria for the bench test according to the recognized consensus" for E.O. gas sterilization, which is a different method than the predicate's Gamma Sterilization, but deemed not to have a "significant difference." |
| General Characteristics | The device shows "no significant differences in most parameters" compared to the predicate, and "the differences do not affect the substantial equivalence." |
2. Sample sized used for the test set and the data provenance:
The document does not specify sample sizes for any of the bench tests or material evaluations. It refers to "bench test results" generally. It does not involve patient data, so concepts like "country of origin" or "retrospective/prospective" are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML diagnostic tool, and its evaluation relies on established engineering and materials testing standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human adjudication process described for the non-clinical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is not an AI-assisted device, and no MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical epidural catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on compliance with international standards for medical devices (e.g., ISO, ASTM) through various physical and chemical bench tests (tensile strength, leakage, biocompatibility, etc.) and comparison to a legally marketed predicate device.
8. The sample size for the training set:
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set involved.
In summary, the provided FDA 510(k) summary is for a traditional medical device (an anesthesia conduction catheter), not an AI/ML-driven product. Therefore, the detailed questions about AI model performance, data sets, and expert ground truth establishment are not addressed in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2025
JMT Co., Ltd % Dave Kim Regulatory Affairs Consultant Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K241410
Trade/Device Name: EDEN ControlCath Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia conduction catheter Regulatory Class: Class II Product Code: BSO Dated: January 14, 2025 Received: January 14, 2025
Dear Dave Kim:
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.
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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.
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-device-advicecomprehensive-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-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-regulatory
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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,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241410
Device Name
EDEN ControlCath
Indications for Use (Describe)
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
| 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 K241410
The following 510(k) summary is being submitted as required by 21 CFR 868.5120;
| 1. | Submitter: | JMT Co., Ltd.70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si,Gyeonggi-Do, Republic of KoreaTel: +82-31-868-0951International: +82-70-4287-8353Fax: +82-31-868-0952 |
|---|---|---|
| Contact Person:(OfficialCorrespondent) | Mtech Group LLCDave Kim, MBA7505 Fannin St. Suite 610, Houston, TX 77054, USTel: 713-467-2607Email: davekim@mtechgroupllc.com | |
| Date Prepared: | April 30, 2024 | |
| 2. | Device IdentificationDevice Trade Name | EDEN ControlCath |
| Device Trade Name | EDEN ControlCath |
|---|---|
| Common Name | Anesthesia conduction catheter |
| Classification Name, Number | Anesthesia conduction catheter(21 CFR 868.5120) |
| Device Classification | II |
| Product Code | BSO |
3. Predicated or legally marketed devices which are substantially equivalent
Predicated device: K150789, "SPINAUT-E, SPINAUT-I", manufactured by "IMEDICOM Co., Ltd."
Device Description 4.
EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.
5. Intended Patient Population
The device under evaluation may be used in patients who meet the indications and have none of the contraindications.
The general principles of good patient selection and sound surgical judgement apply to the procedures. Pre-operative planning and careful surgical technique are essential to achieve optimal results. Consideration of anatomical loading, soft tissue condition and component placement is critical to minimizing a variety of postoperative complications. This device is intended for ages above 18 years old
6. Statement of Indication for use
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
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7. Non-clinical Test Conclusion
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
oISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
o ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity o ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
o ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity o ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
o ISO 10555-1 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
o ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
o ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
o ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
o ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
o ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
o ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Bench test results allowed to conclude that EDEN ControlCath is substantially equivalent to the predicate devices for its intended use.
8. Clinical Test Conclusion
Clinical testing was not required for this submission.
9. Technical Characteristics and Substantial Equivalence
The EDEN ControlCath is substantially equivalent to SPINAUT-E, SPINAUT-I (K150789). The following comparison table is presented to demonstrate substantial equivalence. The EDEN ControlCath does not have a new intended use. It shows the same specifications as the predicate devices in most parameters. Also, there are no significant differences in some parameters between the EDEN ControlCath and SPINAUT-E, SPINAUT-I (K150789). The EDEN ControlCath and SPINAUT-E, SPINAUT-I (K150789) have been demonstrated as substantial equivalence in technical aspects.
| Candidate Device | Predicate Device | SubstantialEquivalenceAnalysis | |
|---|---|---|---|
| 510(k) Number | K241410 | K150789 | - |
| Device Name | EDEN ControlCath | SPINAUT-ESPINAUT-I | - |
| Manufacturer | JMT Co., Ltd. | IMEDICOM Co., Ltd. | - |
| Product Code | BSO | BSO | - |
| Indication for Use | EDEN ControlCath is used fordelivery of drugs that have beenindicated for the epidural space | SPINAUT-E is used for deliveryof drugs that have beenindicated for the epidural space.SPINAUT-I is intended for thepercutaneous introduction and | SubstantialEquivalence |
| placement of an epiduralcatheter. | |||
| Diameter (O.D.) ofCatheter | EDEN CC & EDEN CC(A): Ø 1.73,EDEN CC(2.1) & EDENCC(2.1A): Ø 2.1 | 1.7mm | No significantdifference: Thesubject devicepassed the testcriteria for theside-by-side test(*) |
| Length of Catheter | 300mm | 300mm/ 315mm/ 330mm | No significantdifference: Thesubject devicepassed the testcriteria for theside-by-side test(*) |
| Key PerformanceSpecification/Characteristics | -. Catheter: Tensile Load, LiquidLeakage, Corrosion Resistance,Fatigue, Flexural Strength-. Trocar: Outer and InnerSurface, Flexural Strength, PullOut, Elasticity, Pierce-. Sheath: Tensile Load, FlexuralStrength-. Guide Wire: Strength | -. Catheter: Tensile Load, LiquidLeakage, Corrosion Resistance,Fatigue, Flexural Strength-. Trocar: Outer and InnerSurface, Flexural Strength, PullOut, Elasticity, Pierce-. Sheath: Tensile Load, FlexuralStrength-. Guide Wire: Strength | Same as predicatedevice(*) |
| Compatible Syringe | Recommended for use with 10ccsyringe | Recommended for use with 10ccsyringe | Same as predicatedevice |
| Infusion port | One port | One port | Same as predicate |
| Raw Materials | ABS, Silicone, PVC, PE, PA,SUS 304, PEEK, SODIUMALUMINO SULPHOSILICATE, Titanium dioxide | SUS 304, PU, ABS, PE, PTFE,ABS, Polyurethane | No significantdifference: Thesubject devicepassed the testcriteria for thebench testaccording to therecognizedconsensusstandard (ISO10993-1 Series). |
| Steering | Steerable | Steerable | Same as predicate |
| Single use | Yes | Yes | Same as predicate |
| Components | Catheter, Trocar, Cathetersheath, Guide wire | Epidural catheter, guide wire,catheter introducer, introducerneedle, and needle cap | SubstantialEquivalence |
| Biocompatibility | All patients directly/indirectlycontacting materials arecompliant with ISO10993requirements. | All patients directly/indirectlycontacting materials arecompliant with ISO10993requirements. | Same as predicate |
| Endoscope capable | Incapable | Incapable | Same as predicate |
| Sterilization | E.O gas Sterilization | Gamma Sterilization | No significantdifference: Thesubject devicepassed the testcriteria for thebench testaccording to therecognizedconsensus |
Table 1. General Device Characteristics Comparison Table
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| 1800standA PETAL STORE ST | |
|---|---|
| 11100ﮩﺎ ﮐﮧ ﮐﺎ ﮐﺎ ﮨﮯ ﮐﮧ ﻟﯿﮯ ﮐﮧ ﺑﺎ |
The subject device and predicate device have no significant differences in most parameters and the differences do not affect the substantial equivalence of the subject device when compared to the predicate device.
| 10. | Conclusion | Based on the testing results and specifications, JMT Co., Ltd.concludes that the subject device is substantially equivalent to thepredicate device. |
|---|---|---|
| 11. | Declarations | This summary includes only information that is also covered in thebody of the 510(k).This summary does not contain any puffery or unsubstantiatedlabeling claims. |
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).