(118 days)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
The SeaSpine Beachside System is an intervertebral fusion device with large central graft windows, which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 and titanium alloy per F136 for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) summary for the SeaSpine Beachside System. It describes the device, its intended use, and its similarities to predicate devices. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, particularly in the context of AI/ML performance.
The "Non-Clinical Testing" section mentions mechanical performance tests (compression, compression-shear, subsidence, wear evaluation, and expulsion testing) and bacterial endotoxin testing. While these are acceptance criteria for the device's mechanical and biological properties, they are not related to an AI/ML algorithm's performance.
The "Clinical Testing" section explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study (which would typically involve human subjects and outcome measures) was performed or required for this 510(k) clearance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and a study to prove they are met, as the provided document does not pertain to an AI/ML device in the way your prompt describes.
If you have a document describing an AI/ML device, please provide that text, and I will do my best to extract the requested information.
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December 3, 2019
SeaSpine Orthopedics Corporation Ms. Aly Alvarez Sr. Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K192132
Trade/Device Name: SeaSpine Beachside System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 31, 2019 Received: November 1, 2019
Dear Ms. Alvarez:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 L. Showalter, Ph.D. Assistant Director (Acting) 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) K192132
Device Name SeaSpine Beachside System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SeaSpine
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address:Phone number:Fax number: | 5770 Armada Drive, Carlsbad CA(760) 216-5622(760) 683-6874 | ||
| Contact person:Email address: | Aly Alvarez, Sr. Regulatory Affairs Specialistalyssa.alvarez@seaspine.com | ||
| Date Prepared: | August 7, 2019 | ||
| Device Name | |||
| Trade Name: | SeaSpine Beachside System | ||
| Common Name: | Intervertebral Body Fusion Device | ||
| Classification Name: | Intervertebral fusion device with bone graft, lumba-(21 CFR 888.3080) | ||
| Class: | II |
Legally Marketed Predicate Devices
Product Code:
MAX
| 510(k) Number | ProductCode | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K082310 | MAX | SeaSpine Spacer System -Pacifica | SeaSpineOrthopedicsCorporation |
| Additional Predicate Devices | |||
| K102026 | MAX | SeaSpine Spacer System -(NanoMetalene) Hollywood | SeaSpineOrthopedicsCorporation |
| K142488 | MAX | SeaSpine Spacer System-(NanoMetalene) Pacifica | SeaSpineOrthopedicsCorporation |
| K173260 | MAX | SeaSpine Spacer System-(NanoMetalene) Pacifica,Hollywood | SeaSpineOrthopedicsCorporation |
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Image /page/4/Picture/2 description: The image contains the logo for SeaSpine. The logo features a stylized wave graphic on the left, followed by the word "SeaSpine" in orange. The wave graphic consists of three curved lines, suggesting motion or water.
Device Description
The SeaSpine Beachside System is an intervertebral fusion device with large central graft windows, which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 and titanium alloy per F136 for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for Use
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
Summary of Technological Characteristics
The SeaSpine Beachside System is similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, manufacturing, etc.) and performance (mechanical safety).
The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), wear evaluation, and expulsion testing was verified for the Beachside System through engineering analysis. Mechanical testing in compression (ASTM F2077) was performed. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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SeaSpine
Conclusions
The submitted data demonstrate that the SeaSpine Beachside System is as safe and as effective as the cited legally marketed predicate.
§ 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.