(338 days)
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No
The summary describes a physical implant (PEEK cage) and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for intervertebral body spinal fusion procedures to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The device is an implantable cage designed for spinal fusion procedures, not for diagnosing medical conditions. It is used to stabilize the spine and facilitate bone growth.
No
The device description explicitly states the device is an implant made of PEEK and Titanium alloy, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The INNESIS PEEK Cage is an implantable device designed for spinal fusion surgery. It is physically placed within the patient's body to stabilize the spine.
- Lack of Diagnostic Testing: The description and intended use do not mention any form of testing on biological samples or providing diagnostic information.
Therefore, the INNESIS PEEK Cage falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The INNESIS PEEK Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The INNESIS PEEK implant incorporates ridges on both its superior and inférior surfaces to help eliminate migration. A graft space help facilitate bony integration once implanted. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spinal column, L2-S1
Indicated Patient Age Range
skeletally mature patients
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing method for the INNESIS PEEK Cage followed ASTM F2077-11, "Test Methods for Intervertebral Body Fusion Devices." ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression." and ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices," Draft #2 - August 29, 2000.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
JAN 1 8 2013
Exhibit 5 510(k) Summary
New Device: INNESIS PEEK CAGE
1. Submitter and US Official Correspondent
| Submitter: | BK MEDITECH CO., LTD. |
|---|---|
| Address: | 215-5 Yodang-ri, Yanggam-myun, Hwasung-si |
| Gyeonggi-do, 445-930, Korea | |
| Tel: | +82-31-352-9135~8 |
| Fax: | +82-31-352-9134 |
| Contact: | Mr. Byungjun Park, R&D Manager |
| E-mail: | bjpark@bkmeditech.co.kr |
| US Official Correspondent: | Shin Kuk Yoo, Consultant |
|---|---|
| Telephone No.: 714-313-7442 | |
| Fax No.: 801-303-7455 | |
| Email: skyone@LSKBioPartners.com |
2. Device Information
| Proprietary/Trade Name: | INNESIS PEEK CAGE |
|---|---|
| Common/Usual Name: | Intervertebral body fusion device |
| Classification Name: | Orthosis, Intervertebral body fusion device |
| Device Class: | 21 CFR section 888.3080 |
| MAX | |
| Class II |
3. Substantial Equivalence
Substantial equivalence for the INNESIS PEEK Cage is based in its similarities in indication for use, design features, operational principles and material composition when compared to the predicate device cleared under the following submission:
- · K050624 AVSTM PL PEEK Spacer, Stryker Spine Co., Ltd
- · K092162 4CIS PEEK PLIF Cage System, Solco Biomedical Co. Ltd
- K110067 LP Cage, Medyssey Co., Ltd
Description of Device 4.
The INNESIS PEEK Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The INNESIS PEEK implant incorporates ridges on both its superior and inférior surfaces to help eliminate migration. A graft space help facilitate bony integration once
1
implanted. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V).
ട. Indications for Use
The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
6. Performance Testing
The testing method for the INNESIS PEEK Cage followed ASTM F2077-11, "Test Methods for Intervertebral Body Fusion Devices." ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression." and ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices," Draft #2 - August 29, 2000.
مرد ب
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with intertwined snakes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 18, 2013
BK Meditech Co., Ltd. % LSK Biopartners, Incorporated Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City, Utah 84111
Re: K120464
Trade/Device Name: INNESIS PEEK CAGE Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 10, 2012 Received: December 12, 2012
Dear Mr. Yoo:
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 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.
3
Page 2 - Mr. Shin Kuk Yoo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit 4 Indications for Use
510(k) number (if known): _K120464
Device Name: INNESIS PEEK CAGE
Indications for Use:
The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use _________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephanie Bechtold -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K120464