(1127 days)
Not Found
No
The device description and performance studies indicate a mechanical hemostatic agent, with no mention of AI or ML.
Yes
The device is intended to control bleeding from bone surfaces during surgical operations by acting as a mechanical barrier for hemostasis, which directly relates to treating or mitigating a condition.
No
Explanation: The device description states that MERIL - BONEWAX™ is intended to aid mechanically in the control of bleeding from bone surfaces during surgical operations. It acts as a mechanical barrier for hemostasis and does not act biochemically. There is no mention of it being used for diagnostic purposes, such as identifying or evaluating a medical condition.
No
The device description clearly states it is a physical product composed of refined beeswax and isopropyl myristate, supplied as sterile sheets, and used as a mechanical barrier for hemostasis. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used in the control of bleeding from bone surfaces during surgical operations." This describes a direct therapeutic intervention on the patient's body during surgery.
- Device Description: The description details a physical material (bone wax) that acts as a mechanical barrier to control bleeding. It explicitly states it "does not act biochemically and is nonabsorbable."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
MERIL - BONEWAX™ is a surgical hemostatic device, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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
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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)
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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 |
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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
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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
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and found that the test results met the specification of