(172 days)
The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.
The FOCUS Interbody System includes interbody fusion devices for lumbar implantation. The FOCUS-T and FOCUS-TO implants are designed as structural columns to provide surgical stabilization of the lumbar spine. Each interbody has a central cavity to be packed with bone graft material and inferior/superior teeth to resist expulsion. Lateral windows provide for radiographic visualization on most implant sizes. The implants are available with and without the XCELLerate surface coating and in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are supplied sterile.
The provided text describes the 510(k) premarket notification for the "FOCUS Interbody System," a lumbar intervertebral fusion device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing rather than performance in a study involving human subjects or AI-assisted interpretation of medical images. As such, many of the requested elements for an AI/device study (such as MRMC studies, ground truth establishment for image data, or AI-specific acceptance criteria) are not applicable to this specific device submission.
The "study" in this context refers to the performance data obtained from mechanical testing of the device itself, proving its structural integrity and functional characteristics are substantially equivalent to predicates.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM Standards) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077) | Met established criteria |
| Dynamic Axial Compression (ASTM F2077) | Met established criteria |
| Subsidence (ASTM F2267) | Met established criteria |
Note: The document states that "The mechanical test results demonstrate that the FOCUS Interbody System performance is substantially equivalent to the predicate devices." Specific numerical thresholds for acceptance criteria and the exact numerical results for the device are not provided in this summary, but are implicitly deemed acceptable by the FDA's clearance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document refers to "worst case FOCUS Interbody System implant" undergoing testing. This implies a limited, focused sample size for mechanical testing. The exact number of units tested is not specified but is typical for benchtop mechanical validation rather than clinical study sample sizes.
- Data Provenance: The data is generated from laboratory mechanical testing of the device prototypes. This is not patient data; therefore, concepts like country of origin or retrospective/prospective do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not Applicable. For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267) and the physical properties of the materials and design. There are no "experts" establishing ground truth in the sense of medical image interpretation. Engineers and test technicians perform the testing and interpret results against the standards.
4. Adjudication Method for the Test Set:
- Not Applicable. This is mechanical engineering testing against defined standards, not an observational study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This device is a physical medical implant. MRMC studies are relevant for devices that assist in diagnostic interpretation (e.g., AI for radiology). This is not such a device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
- Engineering Standards and Material Properties: The "ground truth" for the performance of the FOCUS Interbody System is established by recognized ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices (F2077 for static/dynamic axial compression and F2267 for subsidence), as well as the known properties of the materials used (Ti6Al4V ELI titanium alloy, titanium powder, calcium phosphate).
8. The Sample Size for the Training Set:
- Not Applicable. This device did not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there was no training set, this question is irrelevant to this device.
In summary, the provided document details the regulatory clearance of a physical medical device based on its mechanical performance demonstrating substantial equivalence to existing devices, adhering to established engineering standards. It does not involve AI, image analysis, or clinical performance studies with human subjects in the contexts typically associated with the acceptance criteria questions.
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October 14, 2022
OC Medical Devices % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026
Re: K221172
Trade/Device Name: FOCUS Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 14, 2022 Received: September 15, 2022
Dear Dr. Warden:
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
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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 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, 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
Enclosure
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Indications for Use
510(k) Number (if known) K221172
Device Name
FOCUS Interbody System
Indications for Use (Describe)
The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.
| 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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510(k) Summary
| Date: | 14 September 2022 |
|---|---|
| Sponsor: | OC Medical Devices |
| 15 East Montgomery Crossroads, Suite 3 | |
| Savannah, GA 31406 | |
| 888-463-5803 | |
| Sponsor Contact: | Jack Mathews, Quality/Operations Manager |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc. |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | FOCUS Interbody System |
| Common Name: | Lumbar interbody fusion device |
| Device Classification: | Class II |
| Regulation Names,Regulation Numbers,Product Codes: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Device Description: | The FOCUS Interbody System includes interbody fusion devices for lumbarimplantation. The FOCUS-T and FOCUS-TO implants are designed asstructural columns to provide surgical stabilization of the lumbar spine. Eachinterbody has a central cavity to be packed with bone graft material andinferior/superior teeth to resist expulsion. Lateral windows provide forradiographic visualization on most implant sizes. The implants are availablewith and without the XCELLerate surface coating and in a variety of height,length, width and lordotic angulation combinations to accommodate thepatient specific anatomy and clinical circumstances. The implants aresupplied sterile. |
| Indications for Use: | The FOCUS Interbody System is intended to be used as a lumbarintervertebral fusion device at one or two adjacent levels from L2 to S1. Thissystem should be limited to skeletally mature patients who have had sixmonths of non-operative care for the treatment of degenerative disc disease(DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involvedspinal level(s). DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies. Inaddition, the FOCUS Interbody System can be used as an adjunct to fusion inpatients diagnosed with degenerative scoliosis. The FOCUS InterbodySystem is intended for use with autograft and/or allograft comprised ofcancellous and/or corticocancellous bone graft and/or demineralizedallograft bone with bone marrow aspirate. These implants are intended foruse with supplemental fixation indicated for lumbar spinal fusion proceduressuch as the OrthoCircle Spine Pedicle Screw System. |
| Materials: | The FOCUS Interbody System implants are manufactured from Ti6Al4V ELItitanium alloy (ASTM F136). The xCELLerate layered coating ismanufactured from titanium powder (ASTM F1580) and calcium phosphate(ASTM F1185 and ASTM F1609). Instruments for implantation of the deviceare manufactured from stainless steel (under ASTM F899), some of whichfeature Radel (polyphenylsulfone) polymer handles. |
| Primary Predicate: | ShurFit 2C Lumbar Interbody Fusion System (Precision Spine Inc. -K212075) |
| Additional Predicate: | Cascadia™ Interbody System (K2M Inc. - K160547, K172009), K190959 |
| Reference Device: | PCM® Cervical Disc System (NuVasive Inc. – P100012) |
| Performance Data: | Mechanical testing of the worst case FOCUS Interbody System implantincluded static and dynamic axial compression according to ASTM F2077and subsidence according to ASTM F2267. |
| The mechanical test results demonstrate that the FOCUS Interbody Systemperformance is substantially equivalent to the predicate devices. | |
| TechnologicalCharacteristics: | The FOCUS Interbody System possesses the many of the sametechnological characteristics as the predicate devices. These include basicdesign, material, method of stabilization, sizes and anatomic location:Differences between the subject and predicate devices included thesubstrate material (vs ShurFit 2C ) and presence of coating (vs Cascadia™)but these did not raise new questions of safety and effectiveness. Thereforethe fundamental scientific technology of the FOCUS Interbody Systemdevices is similar to previously cleared devices. |
| Conclusion: | The FOCUS Interbody System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore theFOCUS Interbody System is substantially equivalent for its intended use. |
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§ 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.