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

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.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "BioGend" Interbody Fusion System 001 Cage. It is used for spinal fusion procedures. This summary focuses on non-clinical performance testing rather than AI/software performance. Therefore, most of the requested information regarding AI/software acceptance criteria and studies is not applicable or cannot be extracted from this document.

However, I can provide information relevant to the non-clinical acceptance criteria and the study that proves the device meets them, as described in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily discusses non-clinical testing for equivalence to a predicate device.

A table of acceptance criteria and the reported device performance:

Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
Sterilization verification	Not explicitly detailed beyond "Sterilization verification" and "The cages are supplied sterile". Implies compliance with relevant standards to ensure sterility.	"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." (Specific data not provided in this summary.)
Shelf life	Not explicitly detailed beyond "Shelf life". Implies compliance with relevant standards to ensure the device remains safe and effective for its designated shelf life.	"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." (Specific data not provided in this summary.)
Biocompatibility	Not explicitly detailed beyond "Biocompatibility". Implies compliance with ISO 10993 series and other relevant standards to ensure the materials are safe for use in the human body.	"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." (Specific data not provided in this summary.)
Performance Testing	Compliance with: - ASTM F2077-22 (Standard Test Methods for Intervertebral Body Fusion Devices)- ASTM F2267-22 (Standard F2267, Standard Test Method for Measuring the Load Bearing Response of a Spinal Implant When Subjected to a Static Compressive Force. Note: The document states 2267-22, which is for compressive load, but the test listed is "static compression-shear test" which typically aligns with F2077-22, and F2267 is specifically for static compression. - FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". Specific tests mentioned include: - Static and dynamic axial compression test - Static compression-shear test - Compressive Subsidence test - Static and dynamic torsional test - Expulsion test Overall Acceptance: The subject device must meet the requirements of its pre-defined acceptance criteria and intended use, and be substantially equivalent to the predicate device. For dimensions, while similar, the device "meets the requirements," implying it is within acceptable ranges for function.	"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." (Specific numerical data from the tests are not included in this summary, only the statement of compliance.) For dimensions, it is stated that even with slight differences, "The performance of the subject device is not affected and meets the requirements. Thus, it would not affect the equivalence."

Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in this 510(k) summary. The summary refers to a "series of tests," but does not quantify the number of devices or observations per test.
- Data Provenance: The tests are non-clinical, likely conducted in a controlled laboratory environment. The submitting company is BioGend Therapeutics Co., Ltd., located in Taipei, Taiwan. The document does not specify the country of origin of the raw data beyond the submitter's location. The data is retrospective in the sense that it was collected prior to submission for FDA review.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to this document. The "ground truth" here is established through mechanical and material testing standards (ASTM, ISO), rather than clinical expert interpretation or labeling of images. The device is a physical interbody fusion cage, not an AI or software device that interprets medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for AI/software, to resolve discrepancies in expert interpretation of clinical data. This document describes non-clinical engineering/materials testing where results are quantitative and compared against established standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable to this document. This device is a physical implant, not an AI-assisted diagnostic or treatment planning software. No clinical studies, MRMC or otherwise, were conducted or referenced for this 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable to this document. This is not an algorithm or software device. Bench testing was done on the physical device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical testing is compliance with established international and FDA-recognized mechanical testing standards (e.g., ASTM F2077-22, ASTM F2267-22) and biomaterial standards (e.g., ASTM F2026 for PEEK, ISO 5832-3 and ASTM F136 for Ti-6Al-4V ELI). These standards define the performance requirements and test methods for such devices.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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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).

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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

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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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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

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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

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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.

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Traditional 510(k) Section 5 - 510(k) Summary

Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	BioGend Therapeutics Co., Ltd.	Paonan Biotech. Co., Ltd.
Trade Name	"BioGend" Interbody Fusion System 001Cage	II-Type Intervertebral Spacer
510(k) No.	(to be assigned)	K180228
Indications forUse/Intended Use	The "BioGend" Interbody Fusion System001 Cage is indicated for intervertebral bodyfusion procedures in skeletally maturepatients with degenerative disc disease(DDD) at one or two contiguous levels fromL2-S1. This device is to be used withautograft bone and/or allograft bonecomprised of cancellous and/orcorticocancellous bone graft. DDD is definedas discogenic back pain with degeneration ofthe disc confirmed by patient history andradiographic studies. These patients may alsohave up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). Patientsshould have at least six months ofnon-operative treatment prior to treatmentwith an intervertebral cage. "BioGend"	The II-Type Intervertebral Spacer is indicatedfor intervertebral body fusion procedures inskeletally mature patients with degenerativedisc disease (DDD) at one or two contiguouslevels from L2-S1. This device is to be usedwith autograft bone and/or allograft bonecomprised of cancellous and/orcorticocancellous bone graft. DDD is definedas discogenic back pain with degeneration ofthe disc confirmed by patient history andradiographic studies. These patients may alsohave up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). Patientsshould have at least six months ofnon-operative treatment prior to treatmentwith an intervertebral cage. The II-TypeIntervertebral Spacer is to be implanted via a	Same
Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	BioGend Therapeutics Co., Ltd.	Paonan Biotech. Co., Ltd.
Trade Name	"BioGend" Interbody Fusion System 001Cage	II-Type Intervertebral Spacer
510(k) No.	(to be assigned)	K180228
	Interbody Fusion System 001 Cage is to beimplanted via a direct posterior approach.These devices are intended to be used withsupplemental fixation instrumentation, whichhas been cleared by the FDA for use in thelumbar spine.	direct posterior approach. These devices areintended to be used with supplementalfixation instrumentation, which has beencleared by the FDA for use in the lumbarspine.
Sterile	Yes	Yes	Same
Main Material	Polyetheretherketone (PEEK)	Poly Ether Ether Ketone (PEEK)	Same
Dimensions	Height: 8.0 mm ~ 14.0 mmLength: 26, 28, 30, 32 and 36 mm	Height: 8.0 mm ~ 14.0 mmLength: 24, 26 and 28 mm	SimilarThe performance of thesubject device is not affectedand meets the requirements.Thus, it would not affect theequivalence.
Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	BioGend Therapeutics Co., Ltd.	Paonan Biotech. Co., Ltd.
Trade Name	“BioGend” Interbody Fusion System 001Cage	II-Type Intervertebral Spacer
510(k) No.	(to be assigned)	K180228
	test, and expulsion test.

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Traditional 510(k) Section 5 - 510(k) Summary

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Traditional 510(k) Section 5 - 510(k) Summary

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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.

Regulation Number and Section

§ 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.