(1127 days)
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.
This document, K200452, pertains to the FDA 510(k) premarket notification for MERIL-BONEWAX™. As a 510(k) submission, it aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be typical for a new device requiring a PMA.
Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to performance tests designed to establish substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of precise quantitative acceptance criteria with corresponding performance values for parameters like sensitivity, specificity, or quantifiable clinical outcomes. Instead, the acceptance criteria are generally qualitative or based on demonstrating equivalence to predicate devices and adherence to established standards.
| Acceptance Criteria Category | Description of Performance Test | Reported Performance / Outcome |
|---|---|---|
| Usability | Kneadability Test | Demonstrated device usability |
| Spreadability Test | Demonstrated device usability | |
| Hemostasis Effectiveness | Animal Performance Test (Porcine Model) | Effective in control of bleeding from the bone surface |
| Biocompatibility | Tests according to ISO 10993-1 | Test results suggest the device is biocompatible |
| Sterilization | Assessed via ISO 11137-1:2006 and ISO 11137-2:2013 | Sterilization method (Gamma irradiation) is established as per standards |
| Bacterial Endotoxin | Limulus amebocyte lysate (LAL) test by Gel Clot Technique | Test results met the specification of < 20 EU/Device |
| Packaging & Shelf Life | Packaging validation (ISO 11607), Shelf life validation (ICH Q1A (R2) & ISO 11607), Transportation Study (ASTM D 999 & ASTM D 5276) | Ensured package integrity throughout the shelf life |
| Substantial Equivalence | Comparison to predicate devices regarding: Intended Use, Material composition, Mechanism of action, Physical Characteristics, Single use, Sterilization, Packaging, Biocompatibility | MERIL - BONE WAX™ is "substantially equivalent" and "as safe and as effective" as the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "kneadability and spreadability tests." For the "animal performance test," it mentions a "porcine model" but does not provide the number of animals used.
- Test Set Sample Sizes: Not explicitly stated for non-animal tests. For the animal performance test, it indicates a "porcine model" without specifying the number of animals.
- Data Provenance: Not explicitly stated whether the data is retrospective or prospective, or the country of origin. Given the submitter's address in Gujarat, India, and the use of ISO/ASTM standards, it's plausible the testing was conducted in India or by a contract research organization adhering to these international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The type of device (bone wax for hemostasis) and the nature of the preclinical tests (bench, animal model) for a 510(k) submission typically do not involve establishing ground truth through expert consensus on diagnostic images or clinical outcomes in the same way as, for example, an AI diagnostic device for radiology. The "ground truth" here is objective performance in mechanical tests, hemostatic efficacy in an animal model, and compliance with recognized standards.
4. Adjudication Method for the Test Set
Not applicable. The tests described (kneadability, spreadability, animal hemostasis, biocompatibility, sterilization, endotoxin, packaging) are objective measurements and do not typically involve human adjudication in the way clinical diagnostic studies might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study is not mentioned. Such a study would be relevant for devices that involve human interpretation of medical data (e.g., radiologists reading images) and the impact of AI assistance. This device is a bone wax, which is a surgical aid, not a diagnostic or AI-driven interpretive tool.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in essence, the preclinical tests described are "standalone" performance evaluations of the device itself (the bone wax) without human intervention in its function (beyond application in the animal model). The device is not an algorithm, so the term "algorithm only" does not apply. The performance tests evaluate the physical properties and biological interactions of the bone wax directly.
7. The Type of Ground Truth Used
The "ground truth" for the various tests mentioned typically refers to:
- Objective measurements and observable outcomes: For kneadability, spreadability, hemostasis in the animal model (e.g., cessation of bleeding, time to hemostasis).
- Established biological and chemical standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11137), and bacterial endotoxin (ANSI/AAMI ST72:2019).
- Engineering and packaging standards: For packaging and shelf life validation (ISO 11607, ICH Q1A (R2), ASTM D 999, ASTM D 5276).
There is no mention of pathology, expert consensus on diagnostic interpretations, or long-term clinical outcomes/data as "ground truth" in this submission.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (bone wax), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this device is not an AI algorithm and does not have a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2023
M/s. Meril Endo Surgery Private Limited Umesh Sharma General Manager - Quality Assurance/Regulatory Affairs Third Floor, E1-E3, Meril Park Survey No, 135/2/B and 174/2, Muktanand Marg, Chala, Vapi - 396191 Gujarat, India
Re: K200452
Trade/Device Name: MERIL-BONEWAX™M Regulatory Class: Unclassified Product Code: MTJ Dated: February 28, 2023 Received: March 6, 2023
Dear Umesh Sharma:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sara S. Thompson -S
For
Laurence D. Coyne, Ph.D. Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200452
Device Name MERIL - BONEWAX™
Indications for Use (Describe)
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "Meril" in white font on a blue background. The "i" in Meril is dotted with two circles, one yellow and one white. The font is sans-serif and appears to be a modern, clean design. The overall impression is simple and professional.
l. Submitter
M/s. Meril Endo Surgery Private Limited Third Floor, E1 - E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India.
Tel. No: +91-260-3052100, Fax: +91-260-3052125 Contact Person: Umesh Sharma E-mail: umesh.sharma@merillife.com Web site: www.merillife.com
Date Prepared: March 23吋, 2023
II. Device
| Trade Name | MERIL - BONEWAX™ |
|---|---|
| Panel | Orthopaedics |
| Common/ Usual Name | Sterilized Bone Wax |
| Classification Name | Wax, Bone |
| Classification | Unclassified |
| Product Code | MTJ |
III. Predicate Device
| Subject device | Predicate device | ||
|---|---|---|---|
| Trade Name | Manufacturer | 510 (K) No. | |
| Meril-Bone Wax™ | CP Medical Bone Wax(Primary Predicate Device) | CP Medical Inc. | K024372 |
| Sharpoint Lukens"Bone Wax | Surgical Specialities Corporation | K050292 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "Meril" in a sans-serif font on a blue background. The letters are white, except for two dots above the "i" which are yellow. The word is centered on the blue background, and there is a white line below the blue background.
IV. Device Description
MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor.
lt is available as 2 or 2.5gm bone wax per pack.
MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.
V. Intended Use
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
VI. Substantial Equivalence
The MERIL – BONE WAX™ is substantially equivalent to marketed predicate devices with respect to intended use and physical characteristics. The MERIL - BONE WAX™ has the same mechanism of action as predicate devices. The safety and effectiveness of MERIL – BONE WAX™ has been evaluated for the following performance and safety requirements.
-
- Intended Use
-
- Material composition
-
- Mechanism of action
-
- Physical Characteristics
-
- Single use
-
- Sterilization
-
- Packaging
-
- Biocompatibility
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "Meril" in white font on a blue background. There are two small yellow dots above the "i" in "Meril". The font is sans-serif and appears to be a logo. The image is cropped, showing only the word and the blue background.
VII. Preclinical Data
Performance Tests
Bench testing was conducted on MERIL - BONE WAX™ test like kneadability and spreadability tests were conducted to demonstrate device usability, and an animal performance test in a porcine model were performed using the MERIL – BONE WAX™ to demonstrate that the subject device was effective in control of bleeding from the bone surface.
Biocompatibility
The biocompatibility evaluation for MERIL – BONE WAX™ was conducted in accordance with Guidance document 'Use of International Standard ISO 10993-1, "Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA.
The test results suggest that the subject device is biocompatible.
Sterilisation
MERIL – BONE WAX™ is sterilized by Gamma irradiation. Method followed for sterilization by gamma irradiation is as per ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and ISO 11137-2: 2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose).
Bacterial Endotoxin Testing
To evaluate the Bacterial Endotoxin for MERIL – BONE WAX™, the Limulas Limulus amebocyte lysate (LAL) test was conducted by Gel Clot Technique
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "Meril" in white font on a blue background. The "i" in Meril has a yellow dot above it. The font is sans-serif and appears to be modern. The blue background is a solid color.
and found that the test results met the specification of < 20 EU/Device in accordance with ANSI/AAMI ST72:2019.
Packaging & Shelf life
Following packaging and shelf life study was conducted to ensure package integrity throughout the shelf life.
- · Packaging validation as per ISO 11607
- · Shelf life validation as per ICH Q1A (R2) & ISO 11607
- Transportation Study as per ASTM D 999 & ASTM D 5276
Conclusion VIII.
MERIL - BONE WAX™ is substantially equivalent to currently marketed devices and presents no substantial differences in composition, intended use and function to predicate device.
The performance, biocompatibility, sterilization, packaging and shelf life study conducted on MERIL – BONE WAX™ demonstrated the device is as safe and as effective as the predicate device. Hence, MERIL - BONE WAX™ will perform as intended in the specified use conditions.
N/A