(77 days)
Not Found
No
The document describes a physical implant (spinal fusion cage) and its intended use, materials, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a PEEK Spinal Fusion Cage, indicated for interbody fusion in patients with Degenerative Disc Disease, which is a medical condition. The device provides support and correction during lumbar interbody fusion surgeries, which clearly points to a therapeutic use.
No
The device is a PEEK Spinal Fusion Cage used for interbody fusion in patients with Degenerative Disc Disease, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of PEEK material with tantalum markers, intended for surgical implantation. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a PEEK Spinal Fusion Cage, which is an implantable device used in surgery to fuse vertebrae. It is a physical device inserted into the body, not a tool for analyzing biological samples.
- Intended Use: The intended use is for interbody fusion in patients with Degenerative Disc Disease, which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The PEEK Spinal Fusion Cage is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature of non-operative treatment. These implants are to be used with autogenous bone graft.
The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an transforaminal approach.
These devices are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The PEEK Spinal Fusion Cage consists of INVIBIO PEEK-OPTIMA LTI lumbar cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The implants are single-use and non-sterile provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbosacral vertebral bodies (L2 to S1)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Healthcare facility/Hospital
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)
Performance - Bench: The following testing standards were utilized to complete bench performance testing:
- ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
- ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Performance - Animal: No animal study data is submitted in this 510(k).
Performance - Clinical: No clinical study data is submitted in this 510(k).
Key results: The PEEK Spinal Fusion Cage is substantially equivalent to the predicate device when evaluating intended use and technological characteristics. The subject device has the identical intended use as the predicate device. The subject device and predicate devices are substantially equivalent with only minor differences regarding: Device sterilization method, Bench performance: static and dynamic compression, static and dynamic compression-shear and subsidence test. These differences do not raise new questions of safety and effectiveness.
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.
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
§ 888.3080 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 3, 2023
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd % Xiaoqing Xue Registration Engineer Sinow Medical AS Vestre Fantoftasen 44, 5072, Bergen Norway
Re: K223776
Trade/Device Name: PEEK Spinal Fusion Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 30, 2022 Received: January 3, 2023
Dear Xiaoqing Xue:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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-regulatoryassistance/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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223776
Device Name PEEK Spinal Fusion Cage
Indications for Use (Describe)
The PEEK Spinal Fusion Cage is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature of non-operative treatment. These implants are to be used with autogenous bone graft.
The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an transforaminal approach.
These devices are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.
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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6. 510(K) Summary
| Preparation Date: | December 30, 2022 | |
|---|---|---|
| Submitter: | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | |
| No. 12, Jinfeng Road, West Taihu Science and Technology Industrial | ||
| Park, Changzhou, Jiangsu, P.R. China | ||
| Jing Huang, Management Representative | ||
| Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | ||
| No. 12, Jinfeng Road, West Taihu Science and Technology Industrial | ||
| Primary Contact | Park, Changzhou, Jiangsu, P.R. China | |
| Postcode: 213149 | ||
| Email: huangjing@geasure.com | ||
| Phone:+86 13656146897 | ||
| Company: Sinow Medical AS | ||
| Designated | ||
| Submission | Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway | |
| Correspondent | Contact Person: Xiaoqing Xue | |
| Telephone: +86 15161196032 | ||
| Email: xue@bergemed.com | ||
| Trade name | PEEK Spinal Fusion Cage | |
| Common name | Intervertebral Body Fusion Device | |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3080 | |
| Subject Device | Product Codes | MAX |
| Classification Panel | Orthopedic | |
| Classification Name | Intervertebral Fusion Device With Bone Graft. | |
| Lumbar | ||
| Manufacturer | Medtronic Sofainor Danek USA, Inc. | |
| Trade name | CAPSTONE® Spinal System | |
| 510(K) Number | K073291 | |
| Regulatory Class | II | |
| Primary Predicate | Regulation Number | 21 CFR 888.3080 |
| Device | Product Codes | MAX |
| Classification Panel | Orthopedic | |
| Classification Name | Intervertebral Fusion Device With Bone Graft. | |
| Lumbar | ||
| FDA Guidance | ||
| Documents | The following FDA guidance documents were consulted to prepare this | |
| premarket notification: | ||
| • Guidance on Medical Device Patient Labeling, issued April 19, | ||
| 2001 | ||
| • Use of International Standard ISO 10993-1, "Biological | ||
| evaluation of medical devices - Part 1: Evaluation and testing | ||
| within a risk management process", issued 2020 | ||
| Intended Use / | The PEEK Spinal Fusion Cage is indicated for interbody fusion with | |
| Indications for Use | autogenous bone graft in patients with Degenerative Disc Disease |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | PEEK Spinal Fusion Cage | Traditional 510(k)
4
| D | |
|---|---|
| (DDD) at one or two levels from L2 to S1. These DDD patients may | |
|---|---|
| also have up to Grade 1 Spondylolisthesis or retrolisthesis at the | |
| involved levels. DDD is defined as discogenic back pain with | |
| degeneration of the disc confirmed by history and radiographic studies. | |
| These patients should be skeletally mature and have had six months of | |
| non-operative treatment.These implants are to be used with autogenous | |
| bone graft. | |
| The PEEK Spinal Fusion Cage may be implanted via an open or a | |
| minimally invasive posterior approach. Alternatively, these implants | |
| may also be implanted via an transforaminal approach. | |
| These devices are intended to be used with supplemental fixation | |
| instrumentation, which has been cleared by the FDA for use in the | |
| lumbar spine. | |
| The PEEK Spinal Fusion Cage consists of INVIBIO PEEK-OPTIMA | |
| LTI lumbar cages of various lengths and heights, which can be inserted | |
| between two lumbar or lumbosacral vertebral bodies to give support and | |
| Device Description | correction during lumbar interbody fusion surgeries. The hollow |
| geometry of the implants allows them to be packed with autogenous | |
| bone graft.The cages contain radiographic tantalum markers used for | |
| both intra and post-operative positioning and visualization. The implants | |
| are single-use and non-sterile provided. | |
| The PEEK Spinal Fusion Cage consists of PEEK cages of various | |
| widths and heights, which can be inserted between two lumbar or | |
| Mechanism of | lumbosacral vertebral bodies to give support and correction during |
| lumbar interbody fusion surgeries. The hollow geometry of the implants | |
| Action | allows them to be packed with autogenous bone graft. It is intended to |
| stabilize spinal segment to promote fusion in order to restrict motion | |
| and decrease pain using bone graft. | |
| Materials | PEEK cages and Tantalum markers |
| Patient Contact | Bone and surrounding tissue |
| Contact Duration | Permanent (>30 days) |
| The devices are provided non-sterile; validated manual cleaning and | |
| Sterilization Method | steam sterilization instructions are provided for the end user before |
| implantation. | |
| Environment of Use | Healthcare facility/Hospital |
| Single Use | Yes |
| Length | 22-36 mm |
| height | 8-16 mm |
| features | a convex, bullet nose design |
| angular teeth | |
| hollow geometry | |
| Material | The following testing standards were utilized to characterize the |
| Characterization | materials: |
| testing | • ISO 13782:2019 Implants for surgery - Metallic materials - Unalloyed |
| tantalum for surgical implant applications |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | PEEK Spinal Fusion Cage | Traditional 510(k)
5
| Biocompatibility
Testing | • ASTM F2026-17 Standard Specification for Polyetheretherketone
(PEEK) Polymers for Surgical Implant Applications |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following testing standards were utilized to evaluate
biocompatibility of the materials: |
| | • ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management process |
| | • ISO 10993-3:2014 Biological evaluation of medical devices -- Part
3:Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity |
| | • ISO 10993-5:2009 Biological evaluation of medical devices -- Part
5: Tests for in vitro cytotoxicity |
| | • ISO 10993-6: 2016 Biological evaluation of medical devices - Part
6:Tests for Local Effects After Implantation |
| | • ISO 10993-10:2010 Biological evaluation of medical devices - Part
10: Tests for irritation and skin sensitization |
| | • ISO 10993-11: 2017 Biological evaluation of medical devices -- Part
11: test for systemic toxicity |
| | • ISO 10993-12:2012 Biological evaluation of medical devices -- Part
12: Sample preparation and reference materials |
| | • ISO 10993-13:2010 Biological evaluation of medical devices - Part
13: Identification and quantification of degradation products from
polymeric medical devices |
| | • ISO 10993-18:2020 Biological evaluation of medical devices - Part |
| 18: Chemical characterization of materials | |
|---|---|
| Performance - | |
| Bench | The following testing standards were utilized to complete bench |
| performance testing: | |
| • ASTM F2077-18 Test Methods for Intervertebral Body Fusion | |
| Devices | |
| • ASTM F2267-04 (Reapproved 2018) Standard Test Method for | |
| Measuring Load Induced Subsidence of Intervertebral Body Fusion | |
| Device Under Static Axial Compression | |
| Performance - | |
| Animal | No animal study data is submitted in this 510(k). |
| Performance - | |
| Clinical | No clinical study data is submitted in this 510(k). |
| The PEEK Spinal Fusion Cage is substantially equivalent to the | |
| predicate device when evaluating intended use and technological |
characteristics. • The subject device has the identical intended use as the predicate device. Substantial The subject device and predicate devices are substantially equivalent Equivalence with only minor differences regarding: • Device sterilization method • Bench performance: static and dynamic compression, static and dynamic compression-shear and subsidence test These differences do not raise new questions of safety and effectiveness.
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Image /page/6/Picture/0 description: The image shows the logo for GEASUR. The logo is in blue and features a stylized font. The 'A' in GEASUR is replaced with a water droplet symbol, emphasizing the company's connection to water or related services.
| Conclusion | Non-clinical data demonstrates the PEEK Spinal Fusion Cage is |
|---|---|
| substantially equivalent to the predicate device. |