(56 days)
Not Found
No
The document describes a passive, physical implant (a spacer) and does not mention any computational or analytical capabilities.
Yes
The device is described as an interbody fusion device (IBD) intended for use in cervical interbody fusion procedures to treat degenerative disc disease. This involves a surgical intervention to directly address a medical condition, which is characteristic of a therapeutic device.
No
Explanation: The device is an implantable spacer used in cervical interbody fusion procedures, not a diagnostic tool. Its purpose is to physically stabilize the spine, not to detect or identify a condition.
No
The device description clearly states it is a physical implant made of PEEK material with Tantalum marker pins, intended for surgical implantation. It also mentions associated Class I instruments. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Ascential IBD PEEKc Spacers are implants used in surgical procedures (cervical interbody fusion) to treat a structural issue (degenerative disc disease) in the spine. They are physical devices inserted into the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its function is purely structural and therapeutic.
Therefore, the Ascential IBD PEEKc Spacer falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 implant with three Tantalum marker pins. The spacers are offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implants have serrations on the top and bottom surfaces of the spacer. The hollow space of the implant is intended to hold bone graft material. The IBD PEEKC spacer is to be used as an interbody fusion device (IBD) for the cervical spine (from C2-C3 to C7-T1).
The Ascential IBD PEEKC Spacers to be used for cervical IBD applications are available in a variety of sizes, from 4 mm to 12 mm in height (in 1 mm increments), two depths: 12 mm and 14 mm and two widths: 14 mm and 16 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to choose the size better suited to the patient's anatomy and pathology.
Class I instruments are provided for successfully performing anterior cervical interbody fusion procedures.
The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of the AVS® AS PEEK Spacer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (from C2-C3 disc to the C7-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 sterilized material of IBD PEEKc has mechanically equivalent material properties to the non-sterile AVS AS implants. Therefore, verification testing conducted for AVS AS is appropriate for the IBD PEEKc implants as they are dimensionally identical. Supporting documentation from Invibio shows of the effects of up to 75kGY gamma sterilization of PEEK-OPTIMA® material, gamma sterilization does not impact mechanical performance of the material. Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2016
Stryker Spine Ms. Tina Mornak Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K161407
Trade/Device Name: Ascential IBD PEEK Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 23, 2016 Received: June 24, 2016
Dear Ms. Mornak:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161407
Device Name Ascential IBD PEEKc Spacer
Indications for Use (Describe)
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had 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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3
Special 510(k) Premarket Notification
| 510(k) Summary: Ascential IBD PEEKC Spacer | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Tina Mornak |
| Regulatory Affairs Specialist | |
| Phone: 201-760-8193 | |
| Fax: 201-962-4070 | |
| Email: tina.mornak@stryker.com | |
| Date Prepared | May 11, 2016 |
| Trade Name | Ascential IBD PEEKC Spacer |
| Common Name | Cervical Interbody Device |
| Proposed Class | Class II |
| Classification Name | |
| and Number | Intervertebral body fixation device |
| 21 CFR §888.3080 | |
| Product Code | ODP |
| Predicate Devices | Primary Predicate: |
| AVS® AS PEEK Spacer (K142251) | |
| Device Description | The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 |
| implant with three Tantalum marker pins. The spacers are offered in a variety | |
| of lengths, heights, and lordotic angles to adapt to varying patient anatomies. | |
| The hollow, ring-shaped implants have serrations on the top and bottom | |
| surfaces of the spacer. The hollow space of the implant is intended to hold | |
| bone graft material. The IBD PEEKC spacer is to be used as an interbody | |
| fusion device (IBD) for the cervical spine (from C2-C3 to C7-T1). |
The Ascential IBD PEEKC Spacers to be used for cervical IBD applications are
available in a variety of sizes, from 4 mm to 12 mm in height (in 1 mm
increments), two depths: 12 mm and 14 mm and two widths: 14 mm and 16
mm. There are also 0° and 4° wedge shaped options that allow the surgeon to
choose the size better suited to the patient's anatomy and pathology.
Class I instruments are provided for successfully performing anterior cervical
interbody fusion procedures.
The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of the
AVS® AS PEEK Spacer |
| Intended Use | The Ascential IBD PEEKC spacers are indicated for use in cervical interbody
fusion procedures in skeletally mature patients with degenerative disc disease
(DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as
back pain of discogenic origin with degeneration of the disc confirmed by
history and radiographic studies.
The Ascential IBD PEEKC spacers are to be used with autogenous bone graft
and/or allogenic bone graft comprised of cancellous and/or corticocancellous
bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKC spacers are intended to be used with supplemental
fixation systems that have been cleared for use in the cervical spine. This
cervical device is to be used in patients who have had six weeks of non-
operative treatment. |
| 510(k) Summary: Ascential IBD PEEKc Spacer | |
| Summary of the
Technological
Characteristics | The subject sterile packed implants have the same technological
characteristics as the non-sterile packed predicate devices. These
characteristics include same design, technical requirements, materials of
construction, and indications/ intended use. Design modifications were not
incorporated to facilitate sterile packaging of the implants. |
| Summary of the
Performance Data | The sterilized material of IBD PEEKc has mechanically equivalent material
properties to the non-sterile AVS AS implants. Therefore, verification testing
conducted for AVS AS is appropriate for the IBD PEEKc implants as they are
dimensionally identical. Supporting documentation from Invibio shows of the
effects of up to 75kGY gamma sterilization of PEEK-OPTIMA® material,
gamma sterilization does not impact mechanical performance of the material.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is
used for pyrogenicity testing to achieve the Endotoxin limit of