(141 days)
Hemasorb Resorbable Hemostatic Bone Putty Applicator is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.
Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. When applied manually to surgically incised or traumatically broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The provided text describes a 510(k) premarket notification for the Hemasorb Resorbable Hemostatic Bone Putty Applicator, focusing on its substantial equivalence to predicate devices rather than a study demonstrating its meeting of specific acceptance criteria through clinical performance metrics against a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment for a standalone algorithm performance study are not available in the provided document. The submission is based on demonstrating substantial equivalence through non-clinical testing.
Here's a breakdown of what can be extracted and what is not available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this submission. The submission is primarily focused on demonstrating "substantial equivalence" to predicate devices, meaning its performance characteristics are similar and equivalent to already-cleared devices, rather than meeting novel performance acceptance criteria for a new clinical claim. The "acceptance criteria" here relate to the successful demonstration of this equivalence for specific characteristics.
| Acceptance Criteria Category | Reported Device Performance (Hemasorb Applicator) |
|---|---|
| Intended Use | Substantially equivalent to predicate devices. |
| Technological Characteristics | Substantially equivalent to predicate devices. |
| Performance | Substantially equivalent to predicate devices. In vitro testing demonstrated this. |
| Specific Performance Tests (Non-Clinical) | (Performed to demonstrate substantial equivalence) |
| Biocompatibility | Demonstrated to be safe and substantially equivalent to the predicate device. |
| - Cytotoxicity | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - Irritation (Intracutaneous Injection) | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - Acute Systemic Injection | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - HPLC Analysis of putty in contact with the dyed plunger | Performed (Implicitly, to ensure no interaction affecting safety/performance and demonstrate substantial equivalence). |
| - Evaluation of Ignition Potential | Performed (Implicitly, to demonstrate safety and substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on in vitro testing to demonstrate substantial equivalence, not a clinical test set with human data. The testing mentioned (cytotoxicity, irritation, etc.) would use laboratory samples, cell cultures, or animal models, but specific "sample sizes" in the context of human data or a defined "test set" as typically understood for AI/algorithm performance studies are not relevant here. Data provenance is therefore also not applicable in the requested sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "ground truth" to establish in the context of an algorithm's performance on a test set, as this was a 510(k) submission for a physical medical device (bone putty applicator) based on substantial equivalence through in vitro testing.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with adjudicated ground truth was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a 510(k) submission for a medical device (bone putty applicator) focusing on substantial equivalence through in vitro testing, not an AI or imaging algorithm. Therefore, no MRMC study looking at human reader improvement with or without AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical applicator for bone putty, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the requested context. The "ground truth" for this submission was established by comparing the physical and chemical characteristics and performance in in vitro tests against the known characteristics and performance of the predicate devices. The "truth" to be established was whether the new device was "substantially equivalent" to existing, legally marketed devices, not clinical outcomes or expert labels on medical images.
8. The Sample Size for the Training Set
Not applicable. There was no training set, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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GIOK Summary
K12 1953
1 of 2
Contact: Howard Schraver Orthocon. Inc. 1 Bridge Street, Suite 121 Invington, NY 10533 Telephone: 914-357-2600 Fax: 914.231.7884 hs.ss@verizon.net Date Prepared: October 21, 2012 Hemasorb® Resorbable Hemostatic Bone Putty Device Trade Name: Applicator Manufacturer: Orthocon. Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 Common Name: Bone wax
Classification Name: Bone wax (unclassified)
Class: Unclassified
Product Code: MTJ
Indications for Use:
Hemasorb Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Device Description:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.
NOV 2 1 2012
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VI 12 1953
2 of 2
47
Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. When applied manually to surgically incised or traumatically broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Substantial Equivalence and Predicate Devices:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator was shown to be substantially equivalent to the devices cleared under K102762, K111575, and K113627 with respect to intended use, technological characteristics and performance.
Performance Testing:
In vitro testing demonstrated that the performance of the Hemasorb Resorbable Hemostatic Bone Putty Applicator was substantially equivalent to that of the predicate devices. The biocompatibility and extractable tests that demonstrate that the materials are safe and substantially equivalent to the predicate device are:
- . Cytotoxicity
- Irritation (Intracutaneous Injection) .
- Acute Systemic Injection .
- HPLC Analysis of putty in contact with the dyed plunger .
- Evaluation of Ignition Potential .
Conclusion:
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb apply) is substantially equivalent to the predicate device with respect to intended use, technological characteristics and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 21, 2012
Orthocon. Incorporated % Richard Kronenthal, Ph.D. Chief Scientific Officer 1 Bridge Street, Suite 121 Irvington, New York 10533
Re: K121953
Trade/Device Name: Hemasorb Apply Regulatory Class: Unclassified Product Code: MTJ Dated: October 21, 2012 Received: October 23, 2012
Dear Dr. Kronenthal:
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Richard Kronenthal, Ph.D.
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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known): K121953
Device Name: Hemasorb Applicator
Hemasorb Resorbable Hemostatic Bone Putty Applicator is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Prescription Use (Part 21 CFR 801 Subpart D)
CONFIDENTIAL
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K121953
N/A