(162 days)
Not Found
No
The summary describes a physical interbody fusion cage made of PEEK and titanium, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests of the device's physical properties.
Yes
The "BioGend" Interbody Fusion System 001 Cage is an implant used for intervertebral body fusion procedures to treat degenerative disc disease, which explicitly states its therapeutic purpose.
No
Explanation: The device is an intervertebral body fusion cage, which is an implant used for treatment/fusion, not a tool for diagnosing medical conditions. The mention of "radios" refers to using radio-graphs to confirm DDD, not that the device itself performs this diagnostic function.
No
The device description clearly states that the "BioGend" Interbody Fusion System 001 Cage is a physical implant made of PEEK and titanium alloy, designed to be inserted into the spine. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device.
- Device Description: The device is a physical implant (a cage) made of PEEK and titanium alloy, designed to be inserted into the spine.
- Nature of IVDs: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such testing.
The device is a medical implant used in a surgical procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The "BioGend" Interbody Fusion System 001 Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment with an intervertebral cage. "BioGend" Interbody Fusion System 001 Cage is to be implanted via a direct posterior 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
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
"BioGend" Interbody Fusion System 001 Cage is designed to be inserted into the intervertebral body space of the spine as an adjunct to fusion. "BioGend"Interbody Fusion System 001 Cage consists of lumbar cages which are available in various heights and lengths to fit the patient's anatomical and physiological requirements. The superior and inferior surfaces of the "BioGend" cages have teeth to help prevent implant dislodgement or expulsion once placed in the desired location. The cages are made of polyetheretherketone (PEEK) which complies with ASTM F2026, and the radiographic markers incorporated into the cages are made of titanium alloy (Ti-6Al-4V ELI) conforming to ISO 5832-3 and ASTM F136. The cages are supplied sterile and intended for single use only. All implants should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of tests were performed to assess the safety and effectiveness of the subject device. All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
The testing includes static and dynamic axial compression test, static compression-shear test, Compressive Subsidence test, static and dynamic torsional test, and expulsion test. These tests are compliance with the requirements of ASTM F2077-22, ASTM F2267-22 and FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
March 6, 2024
BioGend Therapeutics Co. Ltd. Chienpei Chen Senior Specialist 4F., No. 3-2 Park St., Nangang District Taipei, 115 Taiwan
Re: K233075
Trade/Device Name: "BioGend" Interbody Fusion System 001 Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, Dated: December 6, 2023 Received: December 27, 2023
Dear Chienpei Chen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233075
Device Name
"BioGend" Interbody Fusion System 001 Cage
Indications for Use (Describe)
The "BioGend" Interbody Fusion 901 Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment with an intervertebral cage. "BioGend" Interbody Fusion System 001 Cage is to be implanted via a direct posterior 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
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510(k) Section 5 - 510(k) Summary
510(k) SUMMARY
5.1 Type of Submission: Traditional
5.2 Date of Summary: 09/15/2023
- Submitter: BioGend Therapeutics Co., Ltd. 5.3
| Address: | 4F, No. 3-2, Park St., Nangang Dist., Taipei City 115, Taiwan |
|---|---|
| (R.O. C.) | |
| Phone: | +886-2-26558366 |
| Contact: | Chienpei Chen |
| (chienpei.chen@biogend.com.tw) |
5.4 Identification of the Device:
| Proprietary/Trade name: | "BioGend" Interbody Fusion System 001 Cage |
|---|---|
| Classification Product Code: | MAX |
| Regulation Number: | 888.3080 |
| Regulation Description: | Intervertebral Fusion Device With Bone Graft, |
| Lumbar | |
| Review Panel: | Orthopedic |
| Device Class: | II |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | II-Type Intervertebral Spacer |
|---|---|
| Applicant: | Paonan Biotech. Co., Ltd. |
| Classification Product Code: | MAX |
| Regulation number: | 888.3080 |
| Device Class: | II |
| 510(k) Number: | K180228 |
4
Traditional 510(k) Section 5 - 510(k) Summary
5.6 Indications for Use / Intended Use of the Device
The "BioGend" Interbody Fusion System 001 Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. "BioGend" Interbody Fusion System 001 Cage is to be implanted via a direct posterior 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.
5.7 Description of the Device
"BioGend" Interbody Fusion System 001 Cage is designed to be inserted into the intervertebral body space of the spine as an adjunct to fusion. "BioGend"Interbody Fusion System 001 Cage consists of lumbar cages which are available in various heights and lengths to fit the patient's anatomical and physiological requirements. The superior and inferior surfaces of the "BioGend" cages have teeth to help prevent implant dislodgement or expulsion once placed in the desired location. The cages are made of polyetheretherketone (PEEK) which complies with ASTM F2026, and the radiographic markers incorporated into the cages are made of titanium alloy (Ti-6Al-4V ELI) conforming to ISO 5832-3 and ASTM F136. The cages are supplied sterile and intended for single use only. All implants should not be reused under any circumstances.
5
Traditional 510(k) Section 5 - 510(k) Summary
5.8 Non-clinical Testing
A series of tests were performed to assess the safety and effectiveness of the subject device. All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
- . Sterilization verification
- Shelf life
- . Biocompatibility
- Performance testing
The testing includes static and dynamic axial compression test, static compression-shear test, Compressive Subsidence test, static and dynamic torsional test, and expulsion test. These tests are compliance with the requirements of ASTM F2077-22, ASTM F2267-22 and FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".
5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence. The substantial equivalence of the finished "BioGend" Interbody Fusion System 001 Cage have been established through previous nonclinical performance testing.
5.10 Substantial Equivalence Determination
"BioGend" Interbody Fusion System 001 Cage submitted in this 510(k) file is substantially equivalent in indications for use/intended use, technological characteristics, and safety and performance claims to the cleared device, II-Type Intervertebral Spacer (K180228). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
6
Traditional 510(k) Section 5 - 510(k) Summary
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BioGend Therapeutics Co., Ltd. | Paonan Biotech. Co., Ltd. | |
| Trade Name | "BioGend" Interbody Fusion System 001
Cage | II-Type Intervertebral Spacer | |
| 510(k) No. | (to be assigned) | K180228 | |
| Indications for
Use/Intended Use | The "BioGend" Interbody Fusion System
001 Cage is indicated for intervertebral body
fusion procedures in skeletally mature
patients with degenerative disc disease
(DDD) at one or two contiguous levels from
L2-S1. This device is to be used with
autograft bone and/or allograft bone
comprised of cancellous and/or
corticocancellous bone graft. DDD is defined
as discogenic back pain with degeneration of
the disc confirmed by patient history and
radiographic studies. These patients may also
have up to Grade 1 spondylolisthesis or
retrolisthesis at the involved level(s). Patients
should have at least six months of
non-operative treatment prior to treatment
with an intervertebral cage. "BioGend" | The II-Type Intervertebral Spacer is indicated
for intervertebral body fusion procedures in
skeletally mature patients with degenerative
disc disease (DDD) at one or two contiguous
levels from L2-S1. This device is to be used
with autograft bone and/or allograft bone
comprised of cancellous and/or
corticocancellous bone graft. DDD is defined
as discogenic back pain with degeneration of
the disc confirmed by patient history and
radiographic studies. These patients may also
have up to Grade 1 spondylolisthesis or
retrolisthesis at the involved level(s). Patients
should have at least six months of
non-operative treatment prior to treatment
with an intervertebral cage. The II-Type
Intervertebral Spacer is to be implanted via a | Same |
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
| Manufacturer | BioGend Therapeutics Co., Ltd. | Paonan Biotech. Co., Ltd. | |
| Trade Name | "BioGend" Interbody Fusion System 001
Cage | II-Type Intervertebral Spacer | |
| 510(k) No. | (to be assigned) | K180228 | |
| | Interbody Fusion System 001 Cage is to be
implanted via a direct posterior 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. | direct posterior 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. | |
| Sterile | Yes | Yes | Same |
| Main Material | Polyetheretherketone (PEEK) | Poly Ether Ether Ketone (PEEK) | Same |
| Dimensions | Height: 8.0 mm ~ 14.0 mm
Length: 26, 28, 30, 32 and 36 mm | Height: 8.0 mm ~ 14.0 mm
Length: 24, 26 and 28 mm | Similar
The performance of the
subject device is not affected
and meets the requirements.
Thus, it would not affect the
equivalence. |
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
| Manufacturer | BioGend Therapeutics Co., Ltd. | Paonan Biotech. Co., Ltd. | |
| Trade Name | “BioGend” Interbody Fusion System 001
Cage | II-Type Intervertebral Spacer | |
| 510(k) No. | (to be assigned) | K180228 | |
| | test, and expulsion test. | | |
7
Traditional 510(k) Section 5 - 510(k) Summary
8
Traditional 510(k) Section 5 - 510(k) Summary
9
5.11 Similarity and Difference
The "BioGend" Interbody Fusion System 001 Cage is compared with II-Type Intervertebral Spacer. The subject device has same indications for use/intended use, technological characteristics, and similar safety and performance to the predicate device. No specifications are significantly different between these two devices.
Furthermore, the subject device has undergone other safety and performance tests, and the results complied with the testing standards. Therefore, any differences between the subject device and the predicate device are insignificant and do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device as it claims.
5.12 Conclusion
After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the "BioGend" Interbody Fusion System 001 Cage is substantially equivalent to the predicate device.