(1192 days)
Not Found
No
The device is a sterilization pouch and the description focuses on its physical design and sterilization efficacy, with no mention of AI or ML.
No
This device is a sterilization pouch used to enclose dental burs for sterilization, not to treat or diagnose patients.
No
Explanation: The device is a sterilization pouch intended to enclose dental burs for sterilization, not to diagnose medical conditions.
No
The device description clearly indicates a physical sterilization pouch, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose dental burs for sterilization in steam autoclaves and maintain their sterility. This is a process related to the preparation and storage of medical devices, not a diagnostic test performed on biological samples.
- Device Description: The device is a sterilization pouch designed to hold and protect dental burs during and after sterilization. It does not interact with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
The device's function is purely related to the sterilization and storage of medical instruments.
N/A
Intended Use / Indications for Use
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.
Product codes
FRG
Device Description
The Solidence Multipockets is a single use sterilization pouch that features 36 pockets, designed to be used by dentists to enclose small medical devices intended for sterilization in steam autoclaves. The design of the Solidence Multipockets allows the dentists to sterilize 36 dental burs individually, using one sterilization pouch. Each pocket can then be opened independently, without compromising the sterility of the items contained in the other pockets of the sterilization pouch. The Solidence Multipockets is composed of two sheets of laminated film that are heat sealed together to form 36 pockets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
The following tests were performed to demonstrate safety based on current industry standards:
- Sterilization efficacy half cycle sterilization: Pass (No growth)
- Full cycle sterilization: Pass (No growth)
- Drying time: Pass (The mass of the device after sterilization shall not be increased more than 3%.)
- ASTM 10993-5 (Cytotoxicity): Pass (Under the conditions of the testing, non-cytotoxic)
- ASTM F88 Seal Strength: Pass (Seal strength greater than 0.57 Ibf/in)
- ASTM F1929 Dye Penetration: Pass (No channels detected)
No clinical testing was used in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2022
Solidence Surgical Corporation Morris Azad President 2251 San Diego Avenue, Suite B-257 San Fernando, California 91340
Re: K191131
Trade/Device Name: Solidence Multipockets Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 3, 2022 Received: July 7, 2022
Dear Morris Azad:
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 medical devices and radiation-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,
Clarence W. Murray, III, PhD 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
Enclosure
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Indications for Use
510(k) Number (if known) K191131
Device Name Solidence Multipockets
Indications for Use (Describe)
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K191131
DATE PREPARED Aug 1, 2022
MANUFACTURER AND 510(k) OWNER
Solidence Surgical Corporation 1104 San Fernando Road, San Fernando, CA 91340, USA Telephone: Official Contact: Morris Azad, D.D.S., President
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. | |
---|---|
Lucie Dalet, Ph.D. | |
Acknowledge Regulatory Strategies, LLC | |
Telephone: | +1 (619) 458-9547 |
Email: | akomiyama@acknowledge-rs.com |
ldalet@acknowledge-rs.com | |
Website: | acknowledge-rs.com |
DEVICE INFORMATION
Proprietary Name/Trade Name: | Solidence Multipockets |
---|---|
Common Name: | Wrap, Sterilization |
Regulation Number: | 21 CFR 880.6850 |
Class: | II |
Product Code: | FRG |
PREDICATE DEVICE IDENTIFICATION
Proprietary Name/Trade Name: | BH Sterilization Pouch |
---|---|
510(k) Number: | 172280 |
Product Code: | FRG |
Manufactured by: | BH Medical Products Co., Ltd. |
No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin Street | |
Zhonglou District, Changzhou City, Jiangsu Province, | |
People's Republic of China |
DEVICE DESCRIPTION
The Solidence Multipockets is a single use sterilization pouch that features 36 pockets, designed to be used by dentists to enclose small medical devices intended for sterilization in steam autoclaves. The design of the Solidence Multipockets allows the dentists to sterilize 36 dental burs individually, using one sterilization pouch. Each pocket can then be opened independently, without compromising the sterility of the items contained in the other pockets of the sterilization pouch.
4
INDICATIONS FOR USE
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.
Predicate Device | Subject Device | Comparison | |
---|---|---|---|
BH Medical Products Co., Ltd. | Solidence Surgical Corp. | ||
BH Sterilization Pouch | Solidence Multipockets | ||
K172280 | K191131 | ||
Product Code | FRG | FRG | Same |
Indications For Use | The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam autoclaves. The recommended pre- vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch. | The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization. | Different |
Material Composition | Medical Grade Paper, laminate film, polyurethane adhesive, Steam Process Indicator Print Ink | Polymeric laminate film (RPA-202 and RPA-204) | Different |
Sterilization Parameters | Pre-vacuum steam sterilization: 4 minutes at 132°C (270°F). | Gravity steam sterilization: 10 minutes at 275°F (135°C), 30 minutes drying time | Different |
Process Indicator | Yes | No | Different |
Design | The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. | The Solidence Multipockets is composed of two sheets of laminated film that are heat sealed together to form 36 pockets. The design of the Solidence Multipockets allows the dentist to sterilize 36 items individually, using one sterilization sheet. Each pocket can then be opened independently. without | Different |
The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. | compromising the sterility of the items enclosed in the other pockets of the sterilization sheet. | ||
Usage | Single use | Single use | Same |
Configurations / | |||
Dimensions | Single pouch configuration: | ||
#990613: 110 mm x 300 mm | |||
#990616: 90 mm x 230 mm | |||
#990617: 135 mm x 260 mm | |||
#990618: 190 mm x 330 mm | Multiple pockets on one sheet. | ||
Sheet dimensions: 265 mm x 308 mm | |||
Pockets dimensions: 25 mm x 40 mm | Different | ||
Shelf Life | 2 years | 5 years | Different |
Maintenance of | |||
Sterility | 180 days | 1 year | Different |
Biocompatibility | Under the conditions of the testing, noncytotoxic | Under the conditions of the testing, non-cytotoxic | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
5
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate safety based on current industry standards:
Test | Purpose | Acceptance Criteria | Result |
---|---|---|---|
Sterilization efficacy | |||
half cycle sterilization | Demonstrate | ||
adequate sterilization | |||
performance | No growth | Pass | |
Full cycle sterilization | Demonstrate | ||
adequate sterilant | |||
penetration | No growth | Pass | |
Drying time | Demonstrate | ||
adequate drying | |||
performance | The mass of the device | ||
after sterilization shall | |||
not be increased more | |||
than 3%. | Pass | ||
ASTM 10993-5 | Demonstrate pouch | ||
contact during | |||
sterilization will not | |||
produce a cytotoxic | |||
effect in sterilized | |||
devices | Under the conditions of | ||
the testing, | |||
non-cytotoxic | Pass | ||
ASTM F88 Seal | |||
Strength | Demonstrate | ||
adequate sealing | |||
performance | Seal strength greater | ||
than 0.57 Ibf/in | Pass | ||
ASTM F1929 Dye | |||
Penetration | Demonstrate | ||
adequate resistance | |||
to seal leakage | No channels detected | Pass |
Sterilant penetration per ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
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Package integrity and maintenance of package integrity per ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials and ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Accelerated aging per ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Biocompatibility per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
SUMMARY OF CLINICAL TESTING
No clinical testing was used in support of this submission.
CONCLUSION
The conclusions drawn from the non-clinical testing demonstrate that the subject device, Solidence MultiPockets (K191131), is as safe, as effective, and performs as well as or better than the legally marketed predicate (K1712280).