(38 days)
The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.
The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state. The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.
This is a medical device 510(k) premarket notification for a bone staple. It does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to software or AI/ML performance. Therefore, I cannot provide the requested information about AI/ML device performance.
The document describes the OSStaple™ Chill, a nitinol implant for bone fixation. The "Device Description and Testing" section mentions "Bench testing of the OSStaple™ Chill showed that the implants remain in their open martensitic state at operating room temperatures (20°C - 24°C), and fully transform to their closed shape by body temperature (37°C). Testing also showed that both the smooth and barbed versions of the OSStaple™ Chill achieve equivalent or superior pullout resistance to the OSStaple™."
This relates to the physical and mechanical properties of the staple, not to an AI/ML device.
{0}------------------------------------------------
(510(k) Summary)
SEP 3 2010
OSStapleTM Chill Product:
BioMedical Enterprises, Inc. (BME) intends to introduce an addition to the OSStaple™M line of the OSStaple TM Staple System.
Submitter Information
BioMedical Enterprises. Inc. 14785 Omicron Drive. Ste. 205 San Antonio. Texas 78245 Telephone: (210) 677-0354 Contact: Joe W. Soward
Date Prepared:
August 19, 2010
Classification name:
Single/multiple component metallic bone fixation appliances and accessories Common/Usual Name: Bone Staple Proprietary Name: OSStaple™ Chill
IDR
Intended Üse:
The OSStaple TM Chill is indicated for: Fracture and osteotomy fixation and foint arthrodesis of the hand and loot and. Fixation of proximal tibial metaphysis osteotomy.
Product Code:
Device Description and Testing
The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state.
The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.
Bench testing of the OSStaple™ Chill showed that the implants remain in their open martensitic state at operating room temperatures (209C - 249C), and fully transform to. their closed shape by body temperature (37°C). Testing also showed that both the smooth and barbed versions of the OSStaple™ Chill achieve equivalent or superior pullout resistance to the OSStapleTM ..
p 1 of 2
{1}------------------------------------------------
Substantial Equivalence:
The OSStaple TM Chill is substantially equivalent to the predicate BME OSStaple™ cleared by the FDA in K993714.
The FDA has classified these equivalent devices as Class Il:devices (e.g. 21 CFR. 888.3030). The OSStaple™ Chill is a Class II medical device.
(Signature)
Joe W. Soward Director, Quality Assurance and Regulatory Affairs BioMedical Enterprises, Inc.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The caduceus is depicted in a simple, abstract style with thick, black lines. The text is also in black and is written in all capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomedical Enterprises Inc. % Mr. Joe Soward Director, Quality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K102107
SEP 8 2010
Trade/Device Name: OSStaple™ Chill Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and
accessories Regulatory Class: II Product Code: JDR Dated: August 9, 2010 Received: August 10, 2010
Dear Mr. Soward:
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. Iisting 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 801); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 - Mr. Joe Soward
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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Naubare Buehn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Device Name: OSStaple™ Chill
Indications for Use
SEP 8 2010
The OSStaple™ Chill is indicated for:
- Fracture and osteotomy fixation and joint arthrodesis . of the hand and foot and,
- Fixation of proximal tibial metaphysis osteotomy. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)
K102107
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102107
$
§ 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.