(65 days)
The Hemorrhage Occluder Pin is indicated for the control of localized severe presacral hemorrhage during pelvic surgery. When other techniques (cautery, suture, clamping, etc.) are judged ineffective.
The Hemorrhage Occluder Pin is a 7 mm long pin capped with 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.
The provided text describes a medical device called the "Hemorrhage Occluder Pin" and its submission for 510(k) clearance. The submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds or performance targets for a device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The acceptance is based on the new device being "as safe and effective as the predicate device." The "reported device performance" in this context is that its characteristics and function are materially identical to the predicate.
| Characteristic | Acceptance Basis (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate device. | "For the control of localized severe hemorrhage from the presacral area during surgery." (Exactly the same as predicate) |
| Indications for Use | Substantially equivalent to predicate device. | "When other techniques (cautery, suture, clamping, etc.) are judged ineffective." (Exactly the same as predicate) |
| Target Population | Substantially equivalent to predicate device. | "All males or females with the above indication for use." (Exactly the same as predicate) |
| Design | Substantially equivalent to predicate device. | "Developed by reverse engineering the predicate device." (Exactly the same as predicate) |
| Materials | Substantially equivalent to predicate device. | "Machined from medical grade 6AL4V titanium." (Exactly the same as predicate) |
| Performance | Substantially equivalent to predicate device. | "Sterile single use device is pressed thru the tissue and imbedded in the bone... until the head is seated and the bleeding controlled. The pin... remains implanted in the bone. Clinical experience of the product device validates the performance." (Exactly the same as predicate) |
| Biocompatibility | Substantially equivalent to predicate device. | "Titanium is known to be completely inert and immune to corrosion... prior clinical experience with the predicate pins of the same material... validates the biocompatibility." (Exactly the same as predicate) |
| Mechanical Safety | Substantially equivalent to predicate device. | "Supported by materials high strength, corrosion resistance, ability to withstand repeated sterilizations... and by its identical design to the predicate device with its long successful clinical usage." (Exactly the same as predicate) |
| Chemical Safety | Substantially equivalent to predicate device. | "Supported by safe usage of much larger volume of identical material in imbedded prostheses and the materials biocompatibility." (Exactly the same as predicate) |
| Anatomical Sites | Substantially equivalent to predicate device. | "Only site indicated for usage is in the sacral area during pelvic surgery." (Exactly the same as predicate) |
| Human Factors | Substantially equivalent to predicate device. | "Not an issue. Only finger pressure required..." (Exactly the same as predicate) |
| Energy Used or Delivered | Substantially equivalent to predicate device. | "None." (Exactly the same as predicate) |
| Compatibility with environmental and other devices | Substantially equivalent to predicate device. | "Material is highly inert, chemically safe and non-magnetic..." (Exactly the same as predicate) |
| Standards Met | Substantially equivalent to predicate device. | "MIL-T9047 6AL4V EL1 ASTM F136." (Exactly the same as predicate) |
| Electrical Safety | Substantially equivalent to predicate device. | "Device is passive. No electrical input, output or generated power." (Exactly the same as predicate) |
| Thermal Safety | Substantially equivalent to predicate device. | "Device is passive, not heat generating..." (Exactly the same as predicate) |
| Radiation Safety | Substantially equivalent to predicate device. | "Device is immune to damage by any level of radiation exposure..." (Exactly the same as predicate) |
| Sterility | Substantially equivalent to predicate device. | "To be marketed both as 'unsterilized' and as 'sterilized'. The latter will be ETO sterilized and validated in accordance with ANSI/AAMI 11135-1994 and EN550. Sterilization validated per method 'c', half cycle method." (Predicate used radiation sterilization; packaging is "exactly the same"). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of a performance study with a specific sample size. The claim for performance is based on "clinical experience of the product device validates the performance" and "prior clinical experience with the predicate pins." This suggests reliance on existing clinical data and the historical performance of the predicate device, rather than a new prospective study with a defined sample size. The provenance of this "clinical experience" or "prior clinical experience" is not specified (e.g., country of origin, retrospective/prospective).
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)
No information is provided about experts used to establish ground truth. This type of detail is typical for studies involving diagnostic or analytical devices, not typically for mechanical implants demonstrating substantial equivalence where the primary evidence is material equivalence and historical safety data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No test set or adjudication method 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
This is not applicable. The device is a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical implant, and there is no algorithm or standalone performance being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's safety and effectiveness relies on the demonstrated substantial equivalence to a legally marketed predicate device. This includes:
- Material equivalence: Medical grade titanium identical to the predicate.
- Design equivalence: Reverse engineered from the predicate.
- Intended use and indications for use equivalence: Identical to the predicate.
- Historical clinical experience/outcomes data from the predicate device: The document mentions "prior clinical experience with the predicate pins" and "long successful clinical usage" of the predicate. This historical data serves as the "ground truth" for the safety and effectiveness of the device by proxy of its substantial equivalence.
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
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040109 (p. 1 of 3)
510(k) SUMMARY (Section E)
| 1. | Submitted by: | Tools for Surgery, LLC |
|---|---|---|
| 2. | Address: | 1339 Stony Brook RoadStony 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.
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SUBSTANTIAL EQUIVALENCE COMPARISON
| Proposed Device | Predicate Device | |
|---|---|---|
| Intended Use | For the control of localized severehemorrhage from the presacral areaduring surgery. | Exactly the same |
| Indications for Use | When other techniques (cautery, suture,clamping, etc.) are judged ineffective. | Exactly the same |
| Target Population | All males or females with the aboveindication for use. | Exactly the same |
| Design | See item 11 of 510(k) summary (page4.1) and drawing (page 4.4) Theproposed device was developed byreverse engineering the predicate device. | Exactly the same |
| Materials | Machined from medical grade 6AL4Vtitanium as are many orthopedic devicessuch as hip and knee joints and pins,plates and screws, etc. used for internaland external bone fracture fixation | Exactly the same |
| Performance | Sterile single use device is pressed thruthe tissue and imbedded in the bone atthe presacral hemorrhage site (usingfingertip pressure) until the head isseated and the bleeding controlled. Thepin, abetted by the ridges on the pin,remains implanted in the bone. Clinicalexperience of the product devicevalidates the performance. | Exactly the same |
| Biocompatibility | Titanium is known to be completely inertand immune to corrosion by all bodyfluids and tissue and is capable of joiningwith bone and other tissue. Also, theprior clinical experience with thepredicate pins of the same material,sterilized and implanted in the sacral areaduring pelvic surgery validates thebiocompatibility . | Exactly the same, i.esame manufacturingprocess, samechemical composition,same body contact andequivalent sterilizationmethod. |
| Mechanical Safety | Supported by materials high strength,corrosion resistance, ability to withstandrepeated sterilizations withoutcompromise to edge or surface qualityand by its identical design to thepredicate device with its long successfulclinical usage | Exactly the same |
| Chemical Safety | Supported by safe usage of much largervolume of identical material in imbeddedprostheses and the materials bio-compatibility. | Exactly the same |
| Anatomical Sites | Only site indicated for usage is in thesacral area during pelvic surgery. | Exactly the same |
| Human Factors | Not an issue. Only finger pressurerequired to pierce tissue and to press pininto the bone. | Exactly the same |
| Energy Used orDelivered | None. | None |
| Compatibility withenvironmental andother devices | Material is highly inert, chemically safeand non-magnetic and is thus no threat toenvironment or sensitive implanteddevices, 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,output or generated power. | Exactly the same |
| Thermal Safety | Device is passive, not heat generating,and immune to damage from externalheat within range the body can otherwisesustain without fatal consequences. | Exactly the same |
| Radiation Safety | Device is immune to damage by anylevel of radiation exposure the body cansustain and does not emit any radiation. | Exactly the same |
| Sterility | The device is to be marketed both as"unsterilized" and as "sterilized". Thelatter will be ETO sterilized andvalidated in accordance withANSI/AAMI 11135-1994 and EN550.Sterilization validated per method "c",half cycle method.For the sterilized device the packagingshall be a double barrier consisting of atyvek-styrene tray in a tyvek-polyethylene pouch with a five year- expiration. A packaging aging study willbe completed by a certified testing. | Radiation sterilizationwhen marketed assterilized. Packagingand expiration isexactly the same. |
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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.
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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
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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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.