(265 days)
No
The summary describes a physical implant (a cervical interbody fusion cage) and its mechanical testing, with no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is described as an "ACIF Cage" intended for "intervertebral body fusion of the spine," which is a therapeutic intervention aimed at treating cervical disc disease.
No
The device, an Oyster ACIF Cage, is described as an intervertebral body fusion device for the spine, used for anterior cervical interbody fusion. Its purpose is to facilitate fusion and provide structural support, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant (cages) manufactured through SLM and standard milling processes, and the performance studies are based on mechanical testing of this physical device.
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 of the spine, specifically anterior cervical interbody fusion. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is described as a cervical interbody fusion cage, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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 Oyster ACIF Cage has been tested in the following test modes:
- . Static Axial Compression per ASTM F2077
- Static Compression Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compression Shear per ASTM F2077
- Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the Oyster ACIF Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Silony Medical GmbH % Ms. Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918
Re: K182608
Trade/Device Name: Oyster ACIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 13, 2019 Received: May 14, 2019
Dear Ms. May:
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
June 13,2019
1
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 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 (QS) 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 medical devices and radiation-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,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K182608 | |
| Device Name | |
| Oyster ACIF Cage | |
| Indications for Use (Describe) | |
The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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K182608 - 510(K) SUMMARY
| Submitter's Name: | Katharina Barsch
Silony Medical GmbH |
|----------------------------|--------------------------------------------------------------------------------------------------|
| Submitter's Address: | Leinfelder Straße 60
Leinfelden-Echterdingen, Germany D-70771 |
| Submitter's Telephone: | +49 711 78 25 25 40 |
| Additional Contact Person: | Meredith Lee May MS, RAC
Empirical Consulting
719.337.7579
MMay@EmpiricalConsulting.com |
| Date Summary was Prepared: | 18 Sep 2018 |
| Trade or Proprietary Name: | Oyster ACIF Cage |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Abdominal and Surgical Devices Branch (ASDB) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.
INDICATIONS FOR USE
The Oyster CIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster CIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster CIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
TECHNOLOGICAL CHARACTERISTICS
Oyster ACIF Cage is made from Ti6Al4V ELI (Grade 23). The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Materials of manufacture ●
4
- Structural support mechanism ●
- Manufacturing methods ●
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|-----------------------------------------|-------------------------------------------|-------------------|
| K162587 | ROCCIA® ACIF | Silony Medical GmBH | Primary |
| K172888 | EIT Cellular Titanium®
Cervical Cage | EIT Emerging Implant
Technologies GmbH | Additional |
PERFORMANCE DATA
The Oyster ACIF Cage has been tested in the following test modes:
- . Static Axial Compression per ASTM F2077
- Static Compression Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compression Shear per ASTM F2077
- Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the Oyster ACIF Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Oyster ACIF Cage is substantially equivalent to the predicate device.