SPINAUT-V, SPINAUT-S, SPINAUT-I

K151268 · Imedicom Co., Ltd. · HRX · Mar 16, 2016 · Orthopedic

Device Facts

• Record ID: K151268
• Device Name: SPINAUT-V, SPINAUT-S, SPINAUT-I
• Applicant: Imedicom Co., Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. The SPINAUT-S is intended to be used by physicians for the illumination of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease. SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endossope.

Device Story

SPINAUT-V, SPINAUT-S, and SPINAUT-I are arthroscopic tools for epidural space access and visualization. SPINAUT-V is a steerable, single-use flexible catheter with dual infusion ports for drug delivery and endoscope insertion. SPINAUT-S is a reusable, flexible fiberoptic system for tissue illumination and visualization. SPINAUT-I is a single-use introducer for catheter/endoscope placement. Used by physicians in clinical settings; devices facilitate direct visualization of lower spine conditions with minimal musculoskeletal impact. Physicians use visual output to diagnose neural distress and guide therapeutic interventions. Benefits include improved diagnostic accuracy and targeted drug delivery.

Clinical Evidence

Bench testing only. Testing included sterilization validation (ISO 11137, ISO 11737), shelf-life (ASTM F1980-07), biocompatibility (ISO 10993, USP 37), and mechanical performance (leakage, tensile strength, fatigue, X-ray impermeability, flexural rigidity, and optical characteristics per ISO 8600).

Technological Characteristics

Materials: SUS 304, PU, ABS, PE, PTFE, polyamide, optical glass. Energy: Fiberoptic illumination. Connectivity: Compatible with universal camera systems. Sterilization: Gamma (SPINAUT-V/I), non-sterile/reusable (SPINAUT-S). Standards: ISO 10555-1, ISO 8600-1/3, ISO 12233, ISO 594-1/2.

Indications for Use

Indicated for physicians performing epidural space visualization, diagnosis of disease, and drug delivery in the lumbar and sacral spine using a fiberoptic endoscope.

Regulatory Classification

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.

Predicate Devices

• Myelotec Video Guided Catheter (K980734)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2016

IMEDICOM Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, California 92831

Re: K151268

Trade/Device Name: SPINAUT-V. SPINAUT-S. SPINAUT-I Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 12, 2016 Received: February 22, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K151268

Device Name

SPINAUT-V, SPINAUT-S, and SPINAUT-I

#### Indications for Use (Describe)

When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

The SPINAUT-S is intended to be used by physicians for the illumination of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endossope.

| 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)

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# 510(k) Summary

(K151268)

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Mar 15, 2016

## 1. Applicant / Submitter

IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea Tel:[phone] Fax:[phone]

#### 2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device

- Trade Name: SPINAUT-V, SPINAUT-S, and SPINAUT-I
- Common Name: Arthroscope
- י Classification Name: Arthroscope
- Product Code: HRX "
- ' Classification regulation: Class II, 21 CFR 888.1100

#### 4. Predicate Device:

- י Myelotec Video Guided Catheter by Myelotec., Inc (K980734)
#### 5. Description:

SPINAUT-V consists of a flexible catheter, steering handle and associated ports 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

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distress. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain. SPINAUT-V is a sterile, single use device. When placing SPINAUT-V into the patient, SPINAUT-I can be used instead of SPINUT-V as an introducer device.

SPINAUT-S is a surgically invasive flexible fiberoptic system that can be used either with a video guided catheter (SPINAUT-V or other video guided catheters with proper catheter size) or with an introducer device such as SPINAUT-I. The SPINIUT-S is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The SPINAUT-S can be used with the light source and camera system.

SPINAUT-I is intended to be used to prepare or preserve a path for a video guided catheter or an endoscope. It is supplied sterile and for single use.

#### 6. Indication for use:

When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

The SPINAUT-S is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endoscope.

#### 7. Basis for Substantial Equivalence

#### 7.1. SPINAUT-V

SPINUAT-V is substantially equivalent to the Myelotec Video Guided Catheter (K980734) made by Myelotec, Inc.

There are no significant differences between the subject device and the predicate device. They share the following same characteristics.

- Intended Use
- Principle of Operation
- Design
- Size
- Sterilization Method

The materials used in the subject devices might be different from the predicate device (the materials of the predicate device are unknown.); however, the biocompatibility testing results of the subject device support that the subject devices are biocompatible

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and the performance testing results show that the subject device would perform as well as the predicate device. Based on the test results, we conclude that despite the difference, the subject device is substantially equivalent to the predicate device.

| | Subject Device | Predicate Device |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SPINAUT-V | Myelotec Video Guided Catheter |
| 510(k) Number | K151268 | K980734 |
| Manufacturer | IMEDICOM Co., Ltd. | Myelotec., Inc. |
| Product Code | HRX | HRX |
| Intended Use | When used with a fiberoptic<br>endoscope, SPINAUT-V can be used<br>for observing epidural anatomy,<br>pathology and delivery of drugs<br>approved for epidural indications. | When used with a fiberoptic<br>endoscope, this device can be used<br>for observing epidural anatomy,<br>pathology and delivery of drugs<br>approved for epidural indications. |
| Diameter(O.D.) of<br>Catheter | 3.0mm | 2.7 mm, 3.0mm, 3.3mm |
| Lengthof Catheter | 300mm/ 315mm/ 330mm | 300mm |
| Infusion port | Dual ports | Dual ports |
| Material | Sus 304, PU, ABS, PE, PTFE | |
| Steering | Steerable | Steerable |
| Single use | Yes | Yes |
| Components | Video guided catheter, 15G needle,<br>needle cap, introducer, guide wire | Video guided catheter, 15G needle,<br>needle cap, introducer, guide wire |
| Biocompatibility | Biocompatible | Biocompatible |
| Endoscope capable | Capable | Capable |
| Insertion Point | Sacral Hiatus | Sacral Hiatus |
| Sterilization | Gamma Sterilization | Gamma Sterilization |

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### 7.2. SPINAUT-S

SPINUAT-V is substantially equivalent to the Myelotec Video Guided Catheter (K980734) made by Myelotec, Inc.

There are no significant differences between the subject device and the predicate device. They share the following same characteristics.

- Intended Use
- · Principle of Operation
- Materials
- · Design
- · Sterilization Method

The field of view and the observation depth of the subject device are different from the predicate device; however, the performance testing results show that the subject device meets the specifications of those performance characteristics and also supports that it would perform as well as the predicate device. Based on the test results, we conclude that the subject device is substantially equivalent to the predicate device.

| | | Subject Device | Predicate Device |
|------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | | SPINAUT-S | Myelotec Video Guided Catheter |
| 510(k) Number | | K151268 | K980734 |
| Manufacturer | | IMEDICOM Co., Ltd. | Myelotec., Inc. |
| Product Code | | HRX | HRX |
| Intended for use | | The SPINAUT-S is intended to be used by<br>physicians for the illumination and<br>visualization of tissues of the epidural<br>space in the lumbar and sacral spine for<br>the purpose of assisting in the diagnosis of<br>disease. | When used with a fiberoptic endoscope,<br>this device can be used for observing<br>epidural anatomy, pathology and delivery<br>of drugs approved for epidural indications. |
| Performance | | Permits direct visualization of conditions<br>inside the lower spine with minimal<br>impact on the patient's musculoskeletal<br>structure | Permits direct visualization of conditions<br>inside the lower spine with minimal<br>impact on the patient's musculoskeletal<br>structure |
| Material | Optical<br>glass | Inorganic glass | Inorganic glass |
| | Tube | Polyamide | Polyamide |
| | Inner path | Optical fiber | Optical fiber |

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| Performance | Field of view | 90° | 60° |
|-------------------------------|-------------------|------------------------------------------------|------------------------------------------------|
| | Direct view | 0°±10% | 0°±10% |
| | Observation Depth | 3 mm(f₁) ~ 20 mm(f₂) | 5 mm(f₁) ~ 7.0 mm(f₂) |
| Size | Total length | 950.5 mm | 994.0 mm |
| Compatibility w/other devices | | Video Guided Catheter Universal camera systems | Video Guided Catheter Universal camera systems |
| Chemical Safety | | Biocompatible | Biocompatible |
| Sterilization | | Non-sterilized | Non-sterilized |

## 7.3. SPINAUT-I

SPINUAT-V is substantially equivalent to the Myelotec Video Guided Catheter (K980734) made by Myelotec, Inc.

There are no significant differences between the subject device and the predicate device. They share the following same characteristics.

- Intended Use
- Principle of Operation
- · Design
- Materials
- Sterilization Method

We have found no significant differences between the two devices which would raise different questions of safety and effectiveness.

| | Subject Device | Predicate Device |
|---------------|--------------------|--------------------------------|
| Trade name | SPINAUT-I | Myelotec Video Guided Catheter |
| 510(k) Number | K151268 | K980734 |
| Manufacturer | IMEDICOM Co., Ltd. | Myelotec., Inc. |
| Product Code | HRX | HRX |

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| | Intended for use | SPINAUT-I is intended for the<br>percutaneous introduction and<br>placement of Video Guided Catheter<br>and/or Endoscope. | When used with a fiberoptic endoscope,<br>this device can be used for observing<br>epidural anatomy, pathology and<br>delivery of drugs approved for epidural<br>indications. |
|----------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance | To be used to prepare or preserve a path<br>for a lead. | To be used to prepare or preserve a path<br>for a lead. |
| Material | Body | ABS | ABS |
| | Tube | Polyurethane | Polyurethane |
| | Compatibility w/other<br>devices | Video Guided Catheter<br>Endoscope | Video Guided Catheter<br>Endoscope |
| | Chemical Safety | Biocompatible | Biocompatible |
| | 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 with ASTM F1980-07 and the test results validated 3 year shelf life.
- · Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11 and USP 37 <151>, and the test results supported that the subject devices are biocompatible.
- · The following bench tests were performed to evaluate the performance and the safety of the subject devices and the test results met the pre-set criteria.

| No. | Test | Test Description |
|-----|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Appearance | Visual Inspection |
| 2 | Leakage Test<br>(Catheter) | Evaluate if the catheter leaks any water using a pressure<br>gauge |
| 3 | Tensile strength<br>(Catheter) | Test in accordance with ISO 10555-1, Intravascular<br>Catheters - sterile and single use catheter – Part 1:<br>General requirements. |
| 4 | Curved strength<br>(Catheter) | Measure a carved angle of the catheter. |

| SPINA | UT<br>r<br>. V |
|-------|----------------|
| | 1999 |

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| 5 | Fatigue test<br>(Catheter) | Evaluate the fatigue strength of the catheter |
|---|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6 | X-ray impermeable<br>test | Evaluate if the device can be shown on an X-ray image<br>clearly. |
| 7 | Corrosion resistance<br>test | Test in accordance with ISO 10555-1 Intravascular<br>Catheters - sterile and single use catheter - Part 1:<br>General requirements. |
| 8 | Flexural Rigidity<br>(Catheter introducer) | Test in accordance with MFDS Notification No. 2013-<br>214: Standard Specifications for Medical Device –<br>Sterile hypodermic needles for single use - Clause 5. |
| 9 | Sterility test | Test in accordance with Korean Pharmacopeia (10th<br>Edition) : General Requirements for Tests and Assays /<br>Sterility Test |

# SPINAUT-S

| No. | Test | Test Description |
|-----|-------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 1 | Direction of View | Test in accordance with ISO 8600-3 |
| 2 | Field of View | Test in accordance with ISO 8600-3:2013 |
| 3 | (Depth of Focus)<br>Observation Depth | Test in accordance with ISO 8600-1:2005 and ISO<br>12233:2014 |
| 4 | Internal Pressure<br>(Capacity to Resist<br>Pressure) | Test in accordance with ISO 8600-1:2005 |
| 5 | Dimensions | Measure the total length, insertion portion and the outer<br>diameter by vernier calipers. |

# SPINAUT-I

| No. | Test | Test Description |
|-----|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Appearance | Visual Inspection |
| 2 | Leakage Test | Evaluate if the catheter leaks any water using a pressure<br>gauge |
| 3 | Tensile strength | Measure tensile strength of the device |
| 4 | Flexural Rigidity | Test in accordance with MFDS Notification No. 2013-<br>214: Standard Specifications for Medical Device -<br>Sterile hypodermic needles for single use - Clause 5. |
| 5 | Connecting Part<br>(Conical) Fitting | Test in accordance with ISO 594-1 and ISO 594:2.<br>• Gauging test<br>• Liquid leakage<br>• Air leakage<br>• Separation force<br>• Unscrewing torque<br>• Ease of assembly |

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| | | ▪ Resistance to overriding<br>▪ Stress cracking |
|---|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| 6 | Sterility test | Test in accordance with Korean Pharmacopeia<br>(10th Edition) : General Requirements for Tests and<br>Assays / Sterility Test |

The test results supported that the subject device is substantially equivalent to the predicate devices.

#### 9. Conclusion

Based on the similarities, we conclude that the SPINAUT-V, SPINAUT-S, and SPINAUT-I are substantially equivalent to the predicate devices.