(120 days)
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.
The Aesculap® Implant Systems SIBD Spinal System is an implantable spinal device manufactured from polyetheretherketone (PEEK) with tantalum markers. The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.
The provided text describes a medical device, the Aesculap® Implant Systems SIBD Spinal System, and its clearance process. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving device performance.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for a new, novel device. The "performance data" section primarily refers to mechanical testing.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it refers to mechanical testing standards and states that the device is "safe and effective."
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance |
|---|---|
| Mechanical integrity (Static & Dynamic Axial Compression, Shear Compression, Torsion, Subsidence, Expulsion) | Met ASTM F2077/F2267 standards. |
| Substantial Equivalence to predicate devices (K071983, K072253, K081395, K082262, K091301, K073109) | Demonstrated substantial equivalence in materials, shapes, and sizes (as stated in sections "SUBSTANTIAL EQUIVALENCE" and "TECHNOLIGICAL CHARACTERISTICS"). |
| Clinical safety and effectiveness for stated Indications for Use | Implied by "Testing results demonstrate the Aesculap® Implant Systems SIBD Spinal System is safe and effective" and FDA clearance via 510(k). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The performance data discussed is related to mechanical testing, not a clinical test set on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present. The document doesn't describe a clinical study involving experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. No clinical test set with adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC study or AI in this document. This device is a physical spinal implant, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/present. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the parameters defined by the ASTM F2077/F2267 standards. For the overall device, the "ground truth" for FDA clearance is its substantial equivalence to existing predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' past performance and regulatory history. There is no specific, independent "ground truth" derived from patient data described for this 510(k) submission.
8. The sample size for the training set
This information is not present. There is no "training set" in the context of this 510(k) summary for a physical implant.
9. How the ground truth for the training set was established
This information is not present/applicable.
Summary of what the document shows:
The document provides a 510(k) summary for a spinal implant system. The primary method for demonstrating its "safety and effectiveness" and meeting "acceptance criteria" (though not explicitly called that) is by showing:
- Substantial Equivalence: The device is similar in materials, design, and intended use to several already FDA-cleared predicate devices.
- Mechanical Testing: The device successfully passed standard mechanical tests (ASTM F2077/F2267) relevant to spinal implants.
This type of submission typically relies on non-clinical data and comparison to predicates, rather than extensive, new clinical performance studies with defined acceptance criteria and ground truth derived from patient data.
{0}------------------------------------------------
K100802 Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
| Aesculap ® Implant Systems SIBD Spinal SystemJuly 20, 2010 | JUL 20 2010 |
|---|---|
| ---------------------------------------------------------------- | ------------- |
| COMPANY: | Aesculap® Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Lisa M. Boyle610-984-9274 (phone)610-791-6882 (fax) |
| TRADE NAME: | Aesculap® Implant Systems SIBD Spinal System |
| COMMON NAME: | Spinal Implants |
| CLASSIFICATION NAME: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Aesculap® Implant Systems SIBD Spinal System.
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the SIBD Spinal System is substantially equivalent to the Aesculap® Implant Systems PEEK Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STALIF TT System (K073109).
DEVICE DESCRIPTION
The Aesculap® Implant Systems SIBD Spinal System is an implantable spinal device manufactured from polyetheretherketone (PEEK) with tantalum markers. The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.
{1}------------------------------------------------
INDICATIONS FOR USE
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is incent.
As an intervertebral body fusion device designed for use with auto graft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aescular® In least Systems device.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))
The components of the Aesculap® Implant Systems SIBD Spinal System are offered in the same range of shapes and sizes as the predicate devices. The material used for the Aesculap® Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
Static and dynamic testing of the Aesculap® Implant Systems SIBD Spinal System was performed in accordance with ASTM F2077/F2267 (static and dynamic axial compression, static & dynamic shear compression, static & dynamic torsion, subsidence, and expulsion testing) as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Testing results demonstrate the Aesculap® Implant Systems SIBD Spinal System is safe and effective.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G Silver Spring, MD 20993-0002
Aesculap® Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
SEP 12 2011
Re: K100802
Trade/Device Name: Aesculap® Implant Systems SIBD Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: June 10, 2010 Received: June 14, 2010
Dear Ms. Boyle:
This letter corrects our substantially equivalent letter of July 20, 2010.
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(ty the indications for use stated in the enclosure) to legally marketed preditate 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act in clude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
{3}------------------------------------------------
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Much A. Milkeison
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT A.
510(k) Number: K100802
Device Name: Aesculap® Implant Systems SIBD Spinal System
Indications for Use:
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion and radiographic
spinal level(s). spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.
| Prescription Use | X |
|---|---|
| (per 21 CFR 801 100) |
and/or Over-thee-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, . and Restorative Devices
510(k) Number K100802
§ 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.