(342 days)
No
The description focuses on the mechanical steering mechanism and physical properties of the catheter, with no mention of AI or ML.
No.
The device is described as a delivery system for therapeutic agents, not a therapeutic device itself. Its primary function is to facilitate the placement of an epidural catheter and the delivery of drugs, not to provide therapy directly.
No
The device is described as being used for the delivery of drugs to the epidural space and for the introduction and placement of epidural catheters. Its function is to facilitate therapeutic procedures, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a flexible catheter, steering handle, and port, and the performance studies detail testing on these physical attributes (tensile strength, leakage, etc.). There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "delivery of drugs that have been indicated for the epidural space" and for the "percutaneous introduction and placement of an epidural catheter." These are therapeutic and procedural uses, not diagnostic testing performed on samples taken from the body.
- Device Description: The description details a catheter, steering mechanism, and ports for drug delivery. This aligns with a device used for direct intervention within the body, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample to provide diagnostic information.
- Anatomical Site: The device is used within the epidural space, which is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver substances or place a catheter within the body.
N/A
Intended Use / Indications for Use
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 placement of an epidural catheter.
Product codes
BSO
Device Description
SPINAUT-E 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. There are 9 models in SPINAUT-E: E1000, E2000, E1100, E2100, E3100, S1000, S2000, and S3000. The catheter tip of the model E1000, and E3000 can be bent 50° to the left or to the right (the user can rotate the tip to adjust the direction), but the tip of the model E1100, E2100, and E3100 can be bent either direction up to 100°. The S1000, S2000, and S3000 have an extra infusion port for drug so that the other main port can be used for other devices. Each model is characterized by the additional port, the lever, and the dimensions. The SPINAUT-I is intended to be used to prepare or preserve a path for an epidural catheter. When placing SPINAUT-E into the patient, SPINAUT-I can be used as a replacement of the SPINUT-E Catheter Introducer Set. It is supplied sterile and it is for single use. There are 3 models in SPINAUT-I: ID1000, ID2000, and ID3000 and each model is characterized by the length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscope
Anatomical Site
epidural space, lumbar and sacral spine (for predicate device)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
- Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, . 3 and ISO 11737-1. 2. 3. and the test results met the pre-set criteria.
- The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 and the test results validated 3 year shelf life. The following tests were conducted: - SPINAUT-E: Visual Inspection (Appearance), Size Measurement, Leakage Test (Catheter), Tensile strength (Catheter), Curved strength (Catheter), Fatigue test (Catheter), X-ray impermeable test, Corrosion resistance test, Flexural Rigidity (Catheter introducer and the needle), Pulling (Drawing) Test (Catheter introducer and the needle), Package Tensile Test, Package Peeling Test, Package Burst Test, Package Dye Penetration Test, Package Bubble Test, and Sterility Test. - SPINAUT-I: Visual Inspection (Appearance), Size Measurement, Leakage Test, Tensile strength, Flexural Rigidity, Connecting Part (Conical) Fitting, Package Tensile Test, Package Peeling Test, Package Burst Test, Package Dye Penetration Test, Package Bubble Test. and Sterility Test.
- The following biocompatibility tests were performed and the test results supported that the subject devices are biocompatible. - Extraction Test, Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity Test (ISO 10993-11), Pyrogen (USP 37 ), Hoemolysis (ISO 10993-4), Endotoxin-specific LAL (Limulus Amebocyte Lysate) test (USP 38 NF33)
- Various bench tests and sterility test were performed to evaluate the performance and . the safety of the subject devices and the test results met the pre-set criteria. The following tests have been conducted. - SPINUAT-E: Visual Inspection (Appearance), Leakage Test (Catheter), Tensile strength (Catheter), Curved strength (Catheter), Fatigue test (Catheter), X-ray impermeable test. Corrosion resistance test. Flexural Rigidity (Catheter introducer and the needle), Pulling (Drawing) Test (Catheter introducer and the needle), and Sterility Test.
- SPINAUT-I: Visual Inspection (Appearance), Leakage Test, Tensile strength, Flexural Rigidity, Connecting Part (Conical) Fitting, and Sterility Test.
The test results supported that the subject device is substantially equivalent to the predicate devices in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
IMEDICOM Co., Ltd. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110 Fullerton CA 92831
Re: K150789 Trade/Device Name: SPINAUT-E, SPINAUT-I Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia conduction catheter Regulatory Class: Class II Product Code: BSO Dated: January 21, 2016
Received: January 27, 2016
Dear Ms. Priscilla Chung:
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. 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 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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150789
Device Name
SPINAUT-E, SPINAUT-I
Indications for Use (Describe)
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 placement of an epidural catheter.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(k) Summary
(K150789)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Feb 17, 2016
1. Applicant / Submitter
IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea
Tel:+82-31-479-1156 Fax:+82-31-479-1157
2. Submission Correspondent
LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: SPINAUT-E, SPINAUT-I י
- י Common Name: Anesthesia conduction catheter
- Classification Name: Anesthesia conduction catheter י
- ' Product Code: BSO
- Classification regulation: 21 CFR 868.5120 י
4. Predicate Device:
I Primary Predicate Device: Myelotec Video Guided Catheter by Myelotec, Inc. (K980734)
Reference Predicate Device: EBI TargetCath Fluoro-Guided Steerable Catheter I System by EBI, L.P. (K032390)
4
5. Description:
SPINAUT-E 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.
There are 9 models in SPINAUT-E: E1000, E2000, E1100, E2100, E3100, S1000, S2000, and S3000. The catheter tip of the model E1000, and E3000 can be bent 50° to the left or to the right (the user can rotate the tip to adjust the direction), but the tip of the model E1100, E2100, and E 3100 can be bent either direction up to 100°. The S1000, S2000, and S3000 have an extra infusion port for drug so that the other main port can be used for other devices. Each model is characterized by the additional port, the lever, and the dimensions.
The SPINAUT-I is intended to be used to prepare or preserve a path for an epidural catheter. When placing SPINAUT-E into the patient, SPINAUT-I can be used as a replacement of the SPINUT-E Catheter Introducer Set. It is supplied sterile and it is for single use.
There are 3 models in SPINAUT-I: ID1000, ID2000, and ID3000 and each model is characterized by the length.
6. Indication for use:
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 placement of an epidural catheter.
7. Basis for Substantial Equivalence
SPINUAT-E and SPIANTU-I are substantially equivalent to the Myelotec Video Guided Catheter (K980734) made by Myelotec, Inc. and to the EBI TargetCath Fluoro-Guided Steerable Catheter System by EBI, L.P. (K032390).
There are no significant differences between the subject devices and the predicate devices that the subject devices have the similar intended use as the identified predicate devices and they are similar in fundamental scientific technology, design, and size, and they are sterilized via gamma irradiation.
The principles of operation are similar between the subject device and the predicate devices that they consist of a flexible catheter, steering handle and associated port for
5
access to the lumen. The port facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.
In terms of features, the major difference between the subject device and the primary predicate device is that the predicate device has one more designated port allowing the use of a flexible fiber optic endoscope. This is an extra feature that the predicate device offers but the common epidural catheters in the market are guided under fluoroscope as the subject device is, so we believe this difference would not render the device NSE. To support this, we have identified a reference predicate device which has the similar intended use and also used under fluoroscope as the subject device.
The materials used in the subject devices might be different from the predicate devices; however, the biocompatibility testing results of the subject device support that the subject devices are biocompatible. The size and the internal design also might be different between the devices but the performance testing results show that the subject device would perform as well as the predicate devices.
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Device Name | SPINAUT-E | ||
| SPINAUT-I | Myelotec Video Guided Catheter | EBI TargetCath Fluoro-Guided | |
| Steerable Catheter System | |||
| 510(k) Number | - | K980734 | K032390 |
| Product Code | BSO | BSO | BSO |
| Manufacturer | IMEDICOM Co., Ltd. | Myelotec, Inc. | EBI, L.P. |
| Intended Use | 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 | |||
| placement of epidural catheters. | When used with a fiberoptic | ||
| endoscope, this device can be used | |||
| for observing epidural anatomy. | |||
| pathology and delivery of drugs | |||
| approved for epidural indications. | When used with a fluoroscope, the | ||
| EBI® TargetCath™ Fluoro-Guided | |||
| Steerable Catheter System can be | |||
| used in the lumbar and sacral spine | |||
| for delivery of drugs approved for | |||
| epidural indications. The System | |||
| may also be used for the purpose of | |||
| assisting in the diagnosis and | |||
| treatment of disease utilizing a | |||
| caudal approach via the sacral | |||
| hiatus. | |||
| Diameter(O.D.) of | |||
| Catheter | 1.7mm | 2.7mm, 3.0mm, 3.3mm | 2.4mm |
| Length of Catheter | 300mm/ 315mm/ 330mm | 300mm | 280mm |
| Infusion port | One port | Dual port | Dual port |
| Material | SUS 304, PU, ABS, PE, PTFE, | ||
| ABS, Polyurethane | - | - | |
| Steering | Steerable | Steerable | Steerable |
| Single use | Yes | Yes | Yes |
6
| Components | Epidural catheter, guide wire,
catheter introducer, introducer
needle, and needle cap | Epidural catheter, guide wire,
catheter introducer, introducer
needle, and needle cap | Epidural catheter and various
accessories |
|-------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------|
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Endoscope capable | Incapable | Capable | Incapable |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
8. Non-Clinical Testing
- Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, . 3 and ISO 11737-1. 2. 3. and the test results met the pre-set criteria.
- The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 and the test results validated 3 year shelf life. The following tests were conducted: - SPINAUT-E: Visual Inspection (Appearance), Size Measurement, Leakage Test (Catheter), Tensile strength (Catheter), Curved strength (Catheter), Fatigue test (Catheter), X-ray impermeable test, Corrosion resistance test, Flexural Rigidity (Catheter introducer and the needle), Pulling (Drawing) Test (Catheter introducer and the needle), Package Tensile Test, Package Peeling Test, Package Burst Test, Package Dye Penetration Test, Package Bubble Test, and Sterility Test. - SPINAUT-I: Visual Inspection (Appearance), Size Measurement, Leakage Test, Tensile strength, Flexural Rigidity, Connecting Part (Conical) Fitting, Package Tensile Test, Package Peeling Test, Package Burst Test, Package Dye Penetration Test, Package Bubble Test. and Sterility Test.
- · The subject device falls into the category below based on the ISO 10993, Part I. Category: External communicating device (tissue/bone/dentin communicating), Limited exposure (), Hoemolysis (ISO 10993-4), Endotoxin-specific LAL (Limulus Amebocyte Lysate) test (USP 38 NF33)
- Various bench tests and sterility test were performed to evaluate the performance and . the safety of the subject devices and the test results met the pre-set criteria. The following tests have been conducted. - SPINUAT-E: Visual Inspection (Appearance), Leakage Test (Catheter), Tensile strength (Catheter), Curved strength (Catheter), Fatigue test (Catheter), X-ray impermeable test. Corrosion resistance test. Flexural Rigidity (Catheter introducer and the needle), Pulling (Drawing) Test (Catheter introducer and the needle), and Sterility Test.
7
- SPINAUT-I: Visual Inspection (Appearance), Leakage Test, Tensile strength, Flexural Rigidity, Connecting Part (Conical) Fitting, and Sterility Test.
The test results supported that the subject device is substantially equivalent to the predicate devices in safety and effectiveness.
9. Conclusion
Based on the similarities, we conclude that the SPINAUT-E and SPINAUT-I are substantially equivalent to the predicate devices.