(448 days)
Not Found
No
The description focuses on the physical characteristics, materials, and mechanical testing of a spinal implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an intervertebral body fusion device used in surgical procedures to stabilize the cervical spine and promote bone fusion, which is a structural implant rather than a therapeutic device that directly treats disease symptoms.
No
Explanation: The NEST-C Interbody System is an implantable device used for spinal fusion procedures. It is a treatment device, not a diagnostic one, as it is designed to treat degenerative disc disease by promoting intervertebral fusion, rather than identifying or characterizing a disease.
No
The device description clearly states it is an intervertebral body fusion device made from titanium alloy using additive manufacturing, which is a physical implant, not software.
No, 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.
- NEST-C Interbody System Function: The NEST-C Interbody System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a laboratory test.
- Device Description: The description details the physical structure and materials of an implant, not a testing kit or instrument.
The information provided describes a surgical implant used for treatment, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment.
The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Product codes
ODP
Device Description
The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, from C2 to T1 disc.
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)
The worst case devices were subjected to mechanical testing. Testing included static compression, static compression shear, static torsion, dynamic compression, dynamic torsion, and subsidence per ASTM F2077-22 and F2267-04.
NEST-C Interbody System is the same as the predicate device NEST Interbody System in formulation, manufacturing processing, sterilization, and geometry. According to biocompatibility evaluation, current submission met the biocompatibility requirements of ISO 10993-1 and is safe for clinical use. These results demonstrate that the devices are substantially equivalent to the identified predicate devices.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2023
Paonan Biotech Co., Ltd. Penny Huang Associate Product Manager 3F, No.50, Lane 258, Rueiguang Road, Neihu District Taipei City, 114062 Taiwan
Re: K220261
Trade/Device Name: NEST-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 22, 2023 Received: March 22, 2023
Dear Penny Huang:
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
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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
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Indications for Use
510(k) Number (if known) K220261
Device Name NEST-C Interbody System
Indications for Use (Describe)
The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment.
The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical 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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Image /page/3/Picture/0 description: The image shows the logo for BIOMECH Paonan Biotech Co.,Ltd. The word "BIOMECH" is in large, gray, sans-serif font. Below the word "BIOMECH" is the text "Paonan Biotech Co.,Ltd" in a smaller, gray, sans-serif font. To the right of the word "BIOMECH" are two curved shapes, one in blue and one in green.
Paonan Biotech Co., Ltd. NEST-C Interbody System Traditional 510(k)
510(k) Summary
| Submitted by | Paonan Biotech Co., Ltd. | |
|---|---|---|
| 3F., No. 50, Lane 258, Rueiguang Road, Neihu District 11491, Taipei | ||
| City, Taiwan | ||
| Contact Person | Penny Huang | |
| Phone: +886-2-26274366 #608 | ||
| Email: pennyhuang@paonan.com.tw | ||
| Date Prepared | Jan.26,2022 | |
| Common Name | Intervertebral body fusion device | |
| Trade Name | NEST-C Interbody System | |
| Proposed Class | Class II | |
| Classification Name and Number | Intervertebral body fusion device, 21 CFR §888.3080 | |
| Product Code | ODP | |
| Predicate Devices | Legally marketed predicate devices to which substantial equivalence is claimed: Primary predicate: | |
| AVS® AS PEEK Spacer (K142251) Additional predicate: | ||
| NEST Interbody System (K180230) | ||
| Device Description | The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation | |
| systems that have been cleared for use in the cervical spine. | ||
| Intended Use and Indications for Use | The NEST-C Interbody System is indicated for use in cervical | |
| interbody fusion procedures with autogenous bone graft and/or | ||
| allogenic bone graft comprised of cancellous and/or corticocancellous | ||
| bone graft in skeletally mature patients with degenerative disc disease | ||
| (DDD) at one level or multiple contiguous levels from the C2 to T1 | ||
| disc. DDD is defined as neck pain of discogenic origin with | ||
| degeneration of the disc confirmed by history and radiographic | ||
| studies. Patients should be skeletally mature and have six weeks of | ||
| non-operative treatment. | ||
| The NEST-C Interbody System is intended to be used with | ||
| supplemental spinal fixation systems that have been cleared for use in | ||
| the cervical spine. | ||
| Summary of the Technological | ||
| Characteristics | The subject NEST-C Interbody System and the predicates are identical | |
| in indications for use, surgical technique, manufacturing method and | ||
| raw material. | ||
| The subject NEST-C Cage and the predicates share similar design | ||
| features: | ||
| Hollow structure for packing autogenous bone graft and/or | ||
| allogenous bone graft. Serrations on the superior and inferior surfaces Comparable heights, widths, lengths and material | ||
| Summary of | ||
| Non-Clinical Testing | The worst case devices were subjected to mechanical testing. Testing | |
| included static compression, static compression shear, static torsion, | ||
| dynamic compression, dynamic torsion, and subsidence per ASTM | ||
| F2077-22 and F2267-04. | ||
| NEST-C Interbody System is the same as the predicate device NEST | ||
| Interbody System in formulation, manufacturing processing, | ||
| sterilization, and geometry. According to biocompatibility evaluation, | ||
| current submission met the biocompatibility requirements of ISO | ||
| 10993-1 and is safe for clinical use. | ||
| These results demonstrate that the devices are substantially equivalent | ||
| to the identified predicate devices. | ||
| Conclusion | NEST-C Interbody System has demonstrated substantial equivalence | |
| to the identified predicate devices regarding the design features, | ||
| materials used, manufacturing, sterilization, indications for use, and | ||
| results of the mechanical testing. |
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Image /page/4/Picture/1 description: The image shows the logo for BIOMECH. The text "BIOMECH" is in large, gray, sans-serif font. Below the logo is the text "Paonan Biotech Co.,Ltd" in a smaller, gray, sans-serif font. To the right of the logo is a graphic of two curved shapes, one in blue and one in green.
Paonan Biotech Co., Ltd. NEST-C Interbody System Traditional 510(k)
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Image /page/5/Picture/1 description: The image shows the logo for BIOMECH Paonan Biotech Co.,Ltd. The word "BIOMECH" is written in a sans-serif font in gray color. Below the word "BIOMECH" is the text "Paonan Biotech Co.,Ltd" in a smaller font size. To the right of the word "BIOMECH" are two curved shapes, one in blue and one in green.
Paonan Biotech Co., Ltd.
NEST-C Interbody System
Traditional 510(k)