HEMORRHAGE OCCLUDER PIN

{0}------------------------------------------------ 040109 (p. 1 of 3) 510(k) SUMMARY (Section E) | 1. | Submitted by: | Tools for Surgery, LLC | |----|------------------------|----------------------------------------------------| | 2. | Address: | 1339 Stony Brook Road<br>Stony Brook, NY 11790 | | 3. | Telephone: | (631) 751-6930 | | 4. | Fax: | (631) 751-6932 | | 5. | Contact Person: | Arnold R. Leiboff, M.D. | | 6. | Date Summary Prepared: | January 6, 2004 | | 7. | Device Trade Name: | Hemorrhage Occluder Pin | | 8. | Common Name: | Hemorrhage Occluder Pin, also thumbtack | | 9. | Classification Name: | Staple, Implantable (per 21 CFR, Section 878 4750) | Substantial Equivalency is claimed against the following device: Hemorrhage Occluder Pin 10. from Surgin, Inc. 510(k) K890447 Description of the Device: The Hemorrhage Occluder Pin is a 7 mm long pin capped with 11. an 8 mm diameter, 1.5 mm thick truncated conc-shaped head. The 1.25 mm diameter pin section has four tissue and bone retaining ridges formed by machining four equally spaced truncated conical sections. It is made of medical grade titanium suitable for implantation. Intended use of the device: This device is indicated to control severe presacral hemorrhage l 2. during pelvic surgery. Safety and effectiveness of this device: This device is as safe and effective as the predicate 13. device cited above. See tabulated comparison (paragraph 14 below) to validate this claim, Summary comparing technological characteristics with the predicate device. Please find 14. below a tabulated comparison supporting that this device is substantially equivalent to the predicate medical device in commercial distribution. {1}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE COMPARISON | | Proposed Device | Predicate Device | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the control of localized severe<br>hemorrhage from the presacral area<br>during surgery. | Exactly the same | | Indications for Use | When other techniques (cautery, suture,<br>clamping, etc.) are judged ineffective. | Exactly the same | | Target Population | All males or females with the above<br>indication for use. | Exactly the same | | Design | See item 11 of 510(k) summary (page<br>4.1) and drawing (page 4.4) The<br>proposed device was developed by<br>reverse engineering the predicate device. | Exactly the same | | Materials | Machined from medical grade 6AL4V<br>titanium as are many orthopedic devices<br>such as hip and knee joints and pins,<br>plates and screws, etc. used for internal<br>and external bone fracture fixation | Exactly the same | | Performance | Sterile single use device is pressed thru<br>the tissue and imbedded in the bone at<br>the presacral hemorrhage site (using<br>fingertip pressure) until the head is<br>seated and the bleeding controlled. The<br>pin, abetted by the ridges on the pin,<br>remains implanted in the bone. Clinical<br>experience of the product device<br>validates the performance. | Exactly the same | | Biocompatibility | Titanium is known to be completely inert<br>and immune to corrosion by all body<br>fluids and tissue and is capable of joining<br>with bone and other tissue. Also, the<br>prior clinical experience with the<br>predicate pins of the same material,<br>sterilized and implanted in the sacral area<br>during pelvic surgery validates the<br>biocompatibility . | Exactly the same, i.e<br>same manufacturing<br>process, same<br>chemical composition,<br>same body contact and<br>equivalent sterilization<br>method. | | Mechanical Safety | Supported by materials high strength,<br>corrosion resistance, ability to withstand<br>repeated sterilizations without<br>compromise to edge or surface quality<br>and by its identical design to the<br>predicate device with its long successful<br>clinical usage | Exactly the same | | Chemical Safety | Supported by safe usage of much larger<br>volume of identical material in imbedded<br>prostheses and the materials bio-<br>compatibility. | Exactly the same | | | | | | Anatomical Sites | Only site indicated for usage is in the<br>sacral area during pelvic surgery. | Exactly the same | | Human Factors | Not an issue. Only finger pressure<br>required to pierce tissue and to press pin<br>into the bone. | Exactly the same | | Energy Used or<br>Delivered | None. | None | | Compatibility with<br>environmental and<br>other devices | Material is highly inert, chemically safe<br>and non-magnetic and is thus no threat to<br>environment or sensitive implanted<br>devices, electronic or otherwise. | Exactly the same | | Standards Met | MIL-T9047 6AL4V EL1 ASTM F136. | Exactly the same | | Electrical Safety | Device is passive. No electrical input,<br>output or generated power. | Exactly the same | | Thermal Safety | Device is passive, not heat generating,<br>and immune to damage from external<br>heat within range the body can otherwise<br>sustain without fatal consequences. | Exactly the same | | Radiation Safety | Device is immune to damage by any<br>level of radiation exposure the body can<br>sustain and does not emit any radiation. | Exactly the same | | Sterility | The device is to be marketed both as<br>"unsterilized" and as "sterilized". The<br>latter will be ETO sterilized and<br>validated in accordance with<br>ANSI/AAMI 11135-1994 and EN550.<br>Sterilization validated per method "c",<br>half cycle method.<br>For the sterilized device the packaging<br>shall be a double barrier consisting of a<br>tyvek-styrene tray in a tyvek-<br>polyethylene pouch with a five year<br>- expiration. A packaging aging study will<br>be completed by a certified testing. | Radiation sterilization<br>when marketed as<br>sterilized. Packaging<br>and expiration is<br>exactly the same. | {2}------------------------------------------------ K\$\Phi\$t\$\rho\$1\$\varphi\$9 (P.3.\$\rho\$3) : {3}------------------------------------------------ Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. MAR 2 5 2004 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arnold R. Leiboff, M.D. President Tools For Surgery, LLC 1339 Stony Brook Road Stony Brook, New York 11790 Re: K040109 Trade/Device Name: Hemorrhage Occluder Pin Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 6, 2004 Received: January 20, 2004 Dear Dr. Leiboff: 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 cnclosure) 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 such 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); 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. {4}------------------------------------------------ Page 2 - Arnold R. Leiboff, M.D. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark A. Mulkerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known):_K040109 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Hemorrhage Occluder Pin is indicated for the control of iocalized severe presacral e international contributers and in a occlude internal tissue to stop hemorrhage The Hemorrhage Occluder Pin is Indicated for the control of Good of Collection of Stop hemorrhage and aid healing. Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Milliken Division of General, Restorative, and Neurological Devices Page 1 of 1 Number K090104