(100 days)
This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.
The provided text is a 510(k) summary for the Biomet Microfixation Adkins Strut. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment for a new device performance study is not available in the provided text.
The 510(k) summary explicitly states:
"Substantial Equivalence Biomet Microfixation considers the Adkins Struts equivalent to the American V. Mueller Adkins Strut (Pre-amendment device)."
This indicates that the submission relies on the pre-amendment status of the predicate device, implying that extensive new device performance studies to establish specific acceptance criteria were not required in the same way they would be for a novel device. The FDA's letter (Page 1 of the filing) reiterates this by stating they have determined the device is "substantially equivalent...to legally marketed predicate devices."
As a result, I cannot populate the table or answer the specific questions about device performance against acceptance criteria based on this document.
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510(k) Summary
JUL 2 2 2009
Biomet Microfixation Contact: 1520 Tradeport Drive Jacksonville, FL 32218-2480 Kim Reed, Regulatory Affairs Manager 904-741-9443 fax 904-741-3912
| Common or Usual Name: | Bone Plate |
|---|---|
| Classification Name | Single/multiple component metallic bone fixation appliances andaccessories |
| Device Classification: | Class II |
| Device Product Code: | 87HRS (CFR 888.3030) |
Device Name: Adkins Strut
Intended Use: This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
Contraindications:
- 1, Patients with mental or neurological conditions who are unwilling or incapable of following instructions.
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- Patients presenting metal sensitivity reactions.
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- Patients with insufficient quantity of bone or fibrous tissue to allow remodeling.
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- Infection
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- The device should not be used to perform the minimally invasive repair of pectus exavatum (MIRPE or Nuss procedure), or used in conjunctibn with items typically used to perform the MIRPE surgery.
Description: The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.
Sterility Information: The Adkins Struts will be marketed as non-sterile, single use devices.
Possible risks:
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- Metal sensitivity reactions or allergic reaction to the implant material.
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- Pain, discomfort, or abnormal sensation due to the presence of the device.
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- Surgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and other organs, body structures or tissues.
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- Skin irritation, infection, and pneumothorax.
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- Fracture, breakage, migration, or loosening of the implant.
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- Inadequate or incomplete remodeling of the deformity or return of deformity, prior to or after removal of implant.
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- Permanent injury or death.
Substantial Equivalence Biomet Microfixation considers the Adkins Struts equivalent to the American V. Mueller Adkins Strut (Pre-amendment device).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Microfixation, Inc. % Ms. Kim Reed Regulatory Affairs Manager 1520 Tradeport Drive Jacksonville, Florida 32218-2480
JUL 2 2 2009
Re: K091058
Trade/Device Name: Adkins Strut Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 17, 2009 Received: June 19, 2009
Dear Ms. Reed:
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.
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kim Reed
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/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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely, yours,
Barbara Buechum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Indications for Use
510(k) Number (if known): K 09 | 0 S 8
Device Name: Adkins Struts
Indications For Use:
This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
Prescription Use xx_______________________________________________________________________________________________________________________________________________________ AND/OR
Over-The-Counter Use Subpart D) (21 CFR 801 Subpart C)
(Part 21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Onette
(R.L.A.P.)
(Division Sign-0 Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091058
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.