(272 days)
Not Found
No
The summary describes a mechanical steering mechanism and does not mention any AI/ML components or data processing.
No.
The device is used to deliver drugs, but it is not itself a therapeutic agent or device that directly treats a condition. Its function is limited to drug delivery.
No
The device is described as a delivery system for therapeutic agents to the epidural space, not for diagnosing conditions. Its function is to facilitate the connection of syringes to deliver substances.
No
The device description clearly states it consists of physical components like a flexible catheter, steering handle, and a port, indicating it is a hardware device, not software-only.
Based on the provided information, the EDEN ControlCath is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of drugs that have been indicated for the epidural space." This describes a device used in vivo (within the body) for therapeutic purposes (drug delivery).
- Device Description: The description details a physical catheter designed for insertion into the epidural space for drug delivery. This is consistent with an in vivo medical device.
- Anatomical Site: The specified anatomical site is the "epidural space," which is within the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The EDEN ControlCath is a device used to deliver substances into the body.
N/A
Intended Use / Indications for Use
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
Product codes
BSO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
above 18 years old
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 Test Conclusion: The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
o ISO 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.
Clinical Test Conclusion: Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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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4
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 Korea
Tel: +82-31-868-0951
International: +82-70-4287-8353
Fax: +82-31-868-0952 |
|----|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
(Official
Correspondent) | Mtech Group LLC
Dave Kim, MBA
7505 Fannin St. Suite 610, Houston, TX 77054, US
Tel: 713-467-2607
Email: davekim@mtechgroupllc.com |
| | Date Prepared: | April 30, 2024 |
| 2. | Device Identification
Device 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.
5
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 | Substantial
Equivalence
Analysis |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K241410 | K150789 | - |
| Device Name | EDEN ControlCath | SPINAUT-E
SPINAUT-I | - |
| Manufacturer | JMT Co., Ltd. | IMEDICOM Co., Ltd. | - |
| Product Code | BSO | BSO | - |
| Indication for Use | EDEN ControlCath is used for
delivery of drugs that have been
indicated for the epidural space | SPINAUT-E is used for delivery
of drugs that have been
indicated for the epidural space.
SPINAUT-I is intended for the
percutaneous introduction and | Substantial
Equivalence |
| | | placement of an epidural
catheter. | |
| Diameter (O.D.) of
Catheter | EDEN CC & EDEN CC(A)
: Ø 1.73,
EDEN CC(2.1) & EDEN
CC(2.1A)
: Ø 2.1 | 1.7mm | No significant
difference: The
subject device
passed the test
criteria for the
side-by-side test() |
| Length of Catheter | 300mm | 300mm/ 315mm/ 330mm | No significant
difference: The
subject device
passed the test
criteria for the
side-by-side test() |
| Key Performance
Specification/Character
istics | -. 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
-. Guide Wire: Strength | -. 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
-. Guide Wire: Strength | Same as predicate
device(*) |
| Compatible Syringe | Recommended for use with 10cc
syringe | Recommended for use with 10cc
syringe | Same as predicate
device |
| Infusion port | One port | One port | Same as predicate |
| Raw Materials | ABS, Silicone, PVC, PE, PA,
SUS 304, PEEK, SODIUM
ALUMINO SULPHO
SILICATE, Titanium dioxide | SUS 304, PU, ABS, PE, PTFE,
ABS, Polyurethane | No significant
difference: The
subject device
passed the test
criteria for the
bench test
according to the
recognized
consensus
standard (ISO
10993-1 Series). |
| Steering | Steerable | Steerable | Same as predicate |
| Single use | Yes | Yes | Same as predicate |
| Components | Catheter, Trocar, Catheter
sheath, Guide wire | Epidural catheter, guide wire,
catheter introducer, introducer
needle, and needle cap | Substantial
Equivalence |
| Biocompatibility | All patients directly/indirectly
contacting materials are
compliant with ISO10993
requirements. | All patients directly/indirectly
contacting materials are
compliant with ISO10993
requirements. | Same as predicate |
| Endoscope capable | Incapable | Incapable | Same as predicate |
| Sterilization | E.O gas Sterilization | Gamma Sterilization | No significant
difference: The
subject device
passed the test
criteria for the
bench test
according to the
recognized
consensus |
Table 1. General Device Characteristics Comparison Table
6
7
| | 1800
stand
A PETAL STORE ST |
|--|---------------------------------------|
| | 11100
ﮩﺎ 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 the
predicate device. |
|-----|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. | Declarations | This summary includes only information that is also covered in the
body of the 510(k).
This summary does not contain any puffery or unsubstantiated
labeling claims. |