(308 days)
Not Found
No
The 510(k) summary describes a mechanical and optical system for visualization and drug delivery in the epidural space. There is no mention of AI, ML, image processing, or any computational analysis of the visual data. The performance studies focus on mechanical, sterilization, and biocompatibility testing, not algorithmic performance.
No.
The devices are for observation, visualization, diagnosis assistance, and introduction/placement of catheters/endoscopes, not for treating a condition, disease, or injury.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the SPINAUT-S is intended "for the purpose of assisting in the diagnosis of disease" and the "Device Description" section states that the SPINAUT-V allows the physician "to diagnose the potential causes of neural distress and pain."
No
The device description clearly outlines physical components such as a flexible catheter, steering handle, ports, and a fiberoptic system, indicating it is a hardware device. The performance studies also focus on physical characteristics and testing of these hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The SPINAUT devices are used for direct visualization and access within the human body (specifically the epidural space) using a fiberoptic endoscope. They are used for observing anatomy, pathology, and delivering drugs.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens. The diagnosis is based on the physician's visual examination of the internal anatomy.
The SPINAUT devices are surgical/endoscopic devices used for direct visualization and intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space in the lumbar and sacral spine
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)
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 , 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:
- SPINAUT-V: Appearance (Visual Inspection), Leakage Test (Evaluate if the catheter leaks any water using a pressure gauge), Tensile strength (Test in accordance with ISO 10555-1), Curved strength (Measure a carved angle of the catheter.), Fatigue test (Evaluate the fatigue strength of the catheter), X-ray impermeable test (Evaluate if the device can be shown on an X-ray image clearly), Corrosion resistance test (Test in accordance with ISO 10555-1), Flexural Rigidity (Catheter introducer) (Test in accordance with MFDS Notification No. 2013-214: Standard Specifications for Medical Device – Sterile hypodermic needles for single use - Clause 5.), Sterility test (Test in accordance with Korean Pharmacopeia (10th Edition): General Requirements for Tests and Assays / Sterility Test).
- SPINAUT-S: Direction of View (Test in accordance with ISO 8600-3), Field of View (Test in accordance with ISO 8600-3:2013), (Depth of Focus) Observation Depth (Test in accordance with ISO 8600-1:2005 and ISO 12233:2014), Internal Pressure (Capacity to Resist Pressure) (Test in accordance with ISO 8600-1:2005), Dimensions (Measure the total length, insertion portion and the outer diameter by vernier calipers.).
- SPINAUT-I: Appearance (Visual Inspection), Leakage Test (Evaluate if the catheter leaks any water using a pressure gauge), Tensile strength (Measure tensile strength of the device), Flexural Rigidity (Test in accordance with MFDS Notification No. 2013-214: Standard Specifications for Medical Device - Sterile hypodermic needles for single use - Clause 5.), Connecting Part (Conical) Fitting (Test in accordance with ISO 594-1 and ISO 594:2. • Gauging test • Liquid leakage • Air leakage • Separation force • Unscrewing torque • Ease of assembly • Resistance to overriding • Stress cracking), Sterility test (Test in accordance with Korean Pharmacopeia (10th Edition): General Requirements for Tests and Assays / Sterility Test).
The test results supported that the subject device is substantially equivalent to the predicate devices.
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.
Myelotec Video Guided Catheter by Myelotec., Inc (K980734)
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.
0
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
1
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/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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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:+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-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
4
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
5
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 | |
| endoscope, SPINAUT-V can be used | ||
| for observing epidural anatomy, | ||
| pathology and delivery of drugs | ||
| approved for epidural indications. | When used with a fiberoptic | |
| endoscope, this device can be used | ||
| for observing epidural anatomy, | ||
| pathology and delivery of drugs | ||
| approved for epidural indications. | ||
| Diameter(O.D.) of | ||
| 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, | |
| needle cap, introducer, guide wire | Video guided catheter, 15G needle, | |
| needle cap, introducer, guide wire | ||
| Biocompatibility | Biocompatible | Biocompatible |
| Endoscope capable | Capable | Capable |
| Insertion Point | Sacral Hiatus | Sacral Hiatus |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
6
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 | ||
| 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. | When used with a fiberoptic endoscope, | ||
| this device can be used for observing | |||
| epidural anatomy, pathology and delivery | |||
| of drugs approved for epidural indications. | |||
| Performance | Permits direct visualization of conditions | ||
| inside the lower spine with minimal | |||
| impact on the patient's musculoskeletal | |||
| structure | Permits direct visualization of conditions | ||
| inside the lower spine with minimal | |||
| impact on the patient's musculoskeletal | |||
| structure | |||
| Material | Optical | ||
| glass | Inorganic glass | Inorganic glass | |
| Tube | Polyamide | Polyamide | |
| Inner path | Optical fiber | Optical fiber |
7
| 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 |
8
| | Intended for use | SPINAUT-I is intended for the
percutaneous introduction and
placement of Video Guided Catheter
and/or Endoscope. | When used with a fiberoptic endoscope,
this device can be used for observing
epidural anatomy, pathology and
delivery of drugs approved for epidural
indications. |
|----------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance | To be used to prepare or preserve a path
for a lead. | To be used to prepare or preserve a path
for a lead. |
| Material | Body | ABS | ABS |
| | Tube | Polyurethane | Polyurethane |
| | Compatibility w/other
devices | Video Guided Catheter
Endoscope | Video Guided Catheter
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 , 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 | |
| (Catheter) | Evaluate if the catheter leaks any water using a pressure | |
| gauge | ||
| 3 | Tensile strength | |
| (Catheter) | Test in accordance with ISO 10555-1, Intravascular | |
| Catheters - sterile and single use catheter – Part 1: | ||
| General requirements. | ||
| 4 | Curved strength | |
| (Catheter) | Measure a carved angle of the catheter. |
| SPINA | UT
r
. V |
|-------|----------------|
| | 1999 |
9
| 5 | Fatigue test
(Catheter) | Evaluate the fatigue strength of the catheter |
|---|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6 | X-ray impermeable
test | Evaluate if the device can be shown on an X-ray image
clearly. |
| 7 | Corrosion resistance
test | Test in accordance with ISO 10555-1 Intravascular
Catheters - sterile and single use catheter - Part 1:
General requirements. |
| 8 | Flexural Rigidity
(Catheter introducer) | Test in accordance with MFDS Notification No. 2013-
214: Standard Specifications for Medical Device –
Sterile hypodermic needles for single use - Clause 5. |
| 9 | Sterility test | Test in accordance with Korean Pharmacopeia (10th
Edition) : General Requirements for Tests and Assays /
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) | |
| Observation Depth | Test in accordance with ISO 8600-1:2005 and ISO | |
| 12233:2014 | ||
| 4 | Internal Pressure | |
| (Capacity to Resist | ||
| Pressure) | Test in accordance with ISO 8600-1:2005 | |
| 5 | Dimensions | Measure the total length, insertion portion and the outer |
| 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 |
| gauge | ||
| 3 | Tensile strength | Measure tensile strength of the device |
| 4 | Flexural Rigidity | Test in accordance with MFDS Notification No. 2013- |
| 214: Standard Specifications for Medical Device - | ||
| Sterile hypodermic needles for single use - Clause 5. | ||
| 5 | Connecting Part | |
| (Conical) Fitting | Test in accordance with ISO 594-1 and ISO 594:2. | |
| • Gauging test | ||
| • Liquid leakage | ||
| • Air leakage | ||
| • Separation force | ||
| • Unscrewing torque | ||
| • Ease of assembly |
10
| | | ▪ Resistance to overriding
▪ Stress cracking |
|---|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| 6 | Sterility test | Test in accordance with Korean Pharmacopeia
(10th Edition) : General Requirements for Tests and
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.