(155 days)
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.
CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
This document is a 510(k) premarket notification for the CalgaeSeal device and primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner of a typical AI/ML device submission. Therefore, much of the requested information about acceptance criteria, study design, and ground truth for an AI/ML device is not present in this document.
However, based on the provided text, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a topical hemostasis pad and not an AI/ML device, the "acceptance criteria" here refer to the successful completion of standard biological safety tests for medical devices. The performance is reported as "Pass" and "Identical" to the predicate devices.
| Acceptance Criteria (Test) | Reported Device Performance (CalgaeSeal) |
|---|---|
| Biomaterials - skin irritation (ASTM F719) | Pass / Identical |
| Contact Allergens (ASTM F720) | Pass / Identical |
| Intracutaneous Injecting Extracts (ASTM F749) | Pass / Identical |
| Systemic Injections of Extracts (ASTM F750) | Pass / Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "Testing by DeRoyal in 510(k) K914779," suggesting that the current submission relies on the testing performed for a predicate device. Details on the sample size or data provenance for those tests are not in this text.
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):
This information is not applicable to this type of device and submission. The "ground truth" for these tests would be the established safety standards and the results of laboratory tests, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or assessments, which is not the case for these biological safety tests.
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 information is not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the tests mentioned (ASTM F719, F720, F749, F750) would be the specific quantitative and qualitative criteria defined within those ASTM standards for passing or failing the biological safety assessments. These are laboratory-based standards for biomaterial safety.
8. The sample size for the training set:
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
July 28, 2023
BZ Medical Inc. c/o Byron Zahler President 6611 SW Burlingame Avenue Portland, Oregon 97239
Re: K101097 Trade/Device Name: CalgaeSeal Regulatory Class: Unclassified Product Code: QSY
Dear Byron Zahler:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 22, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/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" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BZ Medical, Inc. % Mr. Byron Zahler President 6611 SW Burlingame Avenue Portland, Oregon 97239
Re: K101097
Trade/Device Name: CalgaeSeal Regulatory Class: Unclassified Product Code: FRO Dated: September 10, 2010 Received: September 14, 2010
Dear Mr. Zahler:
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
SEP 22 2010
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Page 2 - Mr. Byron Zahler
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
for Ole Dominiompt
Mark N. Melkerson Dep Dir
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 STATEMENT
510(k) Number (if known): K101097
Device Name: CalgaeSeal
SEP 2 2 2010
Indications for Use:
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page _ of _
co/og.
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510(k) SUMMARY of Safety and Effectiveness (Pursuant to 21 CFR 807.92) September 10, 2010
SEP 22 2010
| Submitted By: | BZ Medical Inc.6611 SW Burlingame AvePortland, OR 97239 | |||
|---|---|---|---|---|
| Contact Person: | Byron ZahlerPresident503 244-7348 | |||
| 2 | Proprietary Name:Common Name:Classification Name: | CalgaeSealTopical Hemostasis PadDressing, Wound, Drug | ||
| Predicate Devices:a. DeRoyal Industriesb. TZ Medicalc. Evolution Medical Tech. | KalginateK914779K040208NeptuneAlgiseal PadK091194 |
4 Device Description:
CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.
CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
5 Device Intended Use:
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve the skin surface for arterial/venous hemostasis at catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Technical Characteristics Summary: б
CalgaeSeal has the same technological characteristics as the predicates devices. Following is a summary of the technological characteristics of CalgaeSeal in comparison to those of the predicate devices.
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| Technical Characteristics | Predicated DevicesKalginate - K914779Neptune - K040208Algiseal Pad - K091194 | CalgaeSeal- K101097 |
|---|---|---|
| Material | Calcium Alginate | Identical |
| Chemical Composition | Mannuronate and Guluronate residues | Identical |
| Design | A sterile, nonwoven fabric pad made of heavy,dense denier calcium alginate fibers. | Identical |
| Function (A); | Absorbent - In moist wound, calcium Alginatechanges to thick fibrous gel that provides a moistenvironment conductive to granulation tissueformation and epithelial growth. | Identical |
| Function (B): | Hemostasis - Concentrates coagulationcomponents by absorbing the fluid componentsof blood. | Identical |
| Testing by DeRoyal in510 (k) K914779: | Standard | Performance |
| Biomaterials - skin irritation | ASTM F719 | PassIdentical |
| Contact Allergens | ASTM F720 | PassIdentical |
| Intracutaneous InjectingExtracts | ASTM F749 | PassIdentical |
| Systemic Injections ofExtracts | ASTM F750 | PassIdentical |
.
1000 - 1000
!
N/A