(338 days)
No
The device is a physical instrument tray for sterilization and transport, with no mention of software, algorithms, or data processing.
No.
The device is an instrument tray designed for organizing, sterilizing, and transporting dental surgical drills and tools, not for providing medical treatment or diagnosis itself.
No
The device is an instrument tray designed to organize, steam sterilize, and transport surgical tools. It does not perform any diagnostic function.
No
The device description clearly states it is a physical instrument tray made of polymer resin, designed to hold and organize dental tools for sterilization and transport. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as holding dental surgical drills and tools for organization, steam sterilization, and transport. This is a function related to the preparation and handling of surgical instruments, not for performing diagnostic tests on biological samples.
- Device Description: The description details a rigid sterilization container designed to hold and protect medical devices during sterilization. This aligns with the function of a medical device accessory used in healthcare settings for instrument management.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples, reagents, or for the purpose of providing diagnostic information about a patient's health status.
Therefore, the Southern Implants Instrument Tray is a medical device accessory used for the sterilization and organization of surgical instruments, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:
- · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
- · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.
The trays are not intended for sterilization of non-porous loads.
The trays are recommended not to be stacked during sterilization.
The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).
Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.
Product codes
KCT
Device Description
The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.
The lid, base and insert are made of Radel R-5000. This material is a polymer resin.
The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.
The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents
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
health care facilities
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
Non-clinical testing was performed according to ISO 17665-1 (sterilization), ISO 17664 / AAMI TIR 12 / AAMI TIR 30 (cleaning), ISO 10993-5 (cytotoxicity), and ASTM D 4169 (transportation).
-
ISO 17665-1 Sterilization of health care products – moist heat - part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices:
- Purpose: To verify the ability of the sterilization process to adequately sterilize the load at 132°C and 135°C
- Acceptance Criteria: 6 log reduction at half cycle
- Results: The ability for successful sterilization at 132°C and 135°C was confirmed.
-
ISO 17664 Processing of health care products – information to be provided by the medical device manufacturer for the processing of medical devices; AAMI TIR 12 Designing, testing, and labelling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; AAMI TIR 30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices:
- Purpose: To verify the effectiveness of the recommended cleaning process.
- Acceptance Criteria: Protein
§ 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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2022
Southern Implants (Pty) Ltd Leith Cumming Official Correspondent 1 Albert Road Irene, Gauteng 0062 South Africa
Re: K210923
Trade/Device Name: Southern Implants Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: February 17, 2022 Received: February 18, 2022
Dear Leith Cumming:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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
2
Indications for Use
510(k) Number (if known) K210923
Device Name Southern Implants Instrument Trays
The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:
- · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
- · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.
The trays are not intended for sterilization of non-porous loads.
The trays are recommended not to be stacked during sterilization.
The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).
Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.
| Size
(L x W x H) | Product Code | Number of
Instruments | Weight of
Tray (g) | Weight of
Full Tray (g) | Vent to Volume
Ratio (in²/in³) | For Use With |
|--------------------------------|--------------|--------------------------|-----------------------|----------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Large | CH-I-ZYG | 19 | 485.5 | 752 | 0.01 | ZAGA Zygomatic Implants (K192651) |
| 26.8 x 14.7 x 5.5 cm | I-ZYG-1 | 25 | 485 | 746 | 0.01 | Zygomatic Implants (K093562: K173343) |
| Medium
18.7 x 13.5 x 5.5 cm | I-HEX-EG | 90 | 348 | 672 | 0.013 | External Hex Implants (K163634; K173706; K003620; K020617; K033171; K052490;
K070841), Provata Implants (K180465) |
| | I-DC-EG | 53 | 386 | 540 | 0.013 | DC Implants (K163060) |
| | I-INT-HEX-EG | 46 | 392 | 555 | 0.013 | Provata Implants (K180465) |
| | I-IT-EG | 49 | 434 | 541 | 0.013 | IT Implants (K061169) |
| | I-MAX-EG | 50 | 386 | 546 | 0.013 | MAX Implants (K071161; K191054) |
| | I-TRI-NEX-EG | 60 | 390 | 547 | 0.013 | Tri-Nex Implants (K070905) |
| Small
14.8 x 9.5 x 5.5 cm | I-PROS-EG | 25 | 180.5 | 280 | 0.014 | Abutments (K003620: K020617; K033171; K052490; K053478; K061169; K070841;
K070905; K071161; K082651; K093562; K163634; K172160; K173343; K173706;
K180465; K181850; K191054; K191250; K192651; K193084) |
| | I-PROS-MINI | 7 | 122.5 | 147 | 0.056 | |
| | I-IV-EG | 47 | 228 | 339 | 0.013 | Inverta Implants (K181850) |
| 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
510(k) Summary
Southern Implants Instrument Trays
28/02/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd
1 Albert Road
Irene, Gauteng, 0062 South Africa
Telephone: +27 12 667 1046
Fax: +27 12 667 1029 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Leith Cumming
Acting Head of Regulatory Affairs and Quality
Email: leith.c@southernimplants.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Southern Implants Instrument Trays |
|---|---|
| Common Name | Instrument Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes and other |
| Accessories | |
| Classification Regulation | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | |
| Reviewing Branch | General Hospital |
| General Hospital |
PREDICATE DEVICE INFORMATION The primary predicate device is K142519 The reference device is K182865.
4
INDICATIONS FOR USE STATEMENT
The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:
- Pre-vacuum Steam At 132°C for 4 minutes with a 20 minutes dry time. ●
- . Pre-vacuum Steam – At 135°C for 3 minutes with a 20 minutes dry time.
The trays are not intended for sterilization of non-porous loads.
The trays are recommended not to be stacked during sterilization.
The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).
Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.
| Size
(L x W x H) | Product
Code | Number of
Instruments | Weight of
Tray (g) | Weight of
Full Tray (g) | Vent to Volume
Ratio (in²/in³) | For Use With |
|-----------------------------------|------------------|--------------------------|-----------------------|----------------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Large
26.8 x 14.7 x
5.5 cm | CH-I-ZYG | 19 | 485.5 | 752 | 0.01 | ZAGA Zygomatic Implants
(K192651) |
| | I-ZYG-1 | 25 | 485 | 746 | 0.01 | Zygomatic Implants
(K093562; K173343) |
| Medium
18.7 x 13.5 x
5.5 cm | I-HEX-EG | 90 | 348 | 672 | 0.013 | External Hex Implants
(K163634; K173706;
K003620; K020617;
K033171; K052490;
K070841)
Provata Implants
(K180465) |
| | I-DC-EG | 53 | 386 | 540 | 0.013 | DC Implants (K163060) |
| | I-INT-
HEX-EG | 46 | 392 | 555 | 0.013 | Provata Implants
(K180465) |
| | I-IT-EG | 49 | 434 | 541 | 0.013 | IT Implants (K061169) |
| | I-MAX-EG | 50 | 386 | 546 | 0.013 | MAX Implants (K071161;
K191054) |
| | I-TRI-NEX-
EG | 60 | 390 | 547 | 0.013 | Tri-Nex Implants (K070905) |
| Small
14.8 x 9.5 x
5.5 cm | I-PROS-EG | 25 | 180.5 | 280 | 0.014 | Abutments (K003620;
K020617; K033171;
K052490; K053478; |
5
| I-PROS-
MINI | 7 | 122.5 | 147 | 0.056 | K061169; K070841;
K070905; K071161;
K082651; K093562;
K163634; K172160;
K173343; K173706;
K180465; K181850;
K191054; K191250;
K192651; K193084) |
|-----------------|----|-------|-----|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| I-IV-EG | 47 | 228 | 339 | 0.013 | Inverta Implants (K181850) |
SUBJECT DEVICE DESCRIPTION
The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.
The lid, base and insert are made of Radel R-5000. This material is a polymer resin.
The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.
The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the subject device and the primary predicate device K142519 is provided in the following table.
6
| Subject Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| Comparison | Instrument Trays | ||
| Southern Implants (Pty) Ltd | K142519 | ||
| InterActive Complete Surgical Tray | |||
| Implant Direct Sybron Manufacturing | |||
| LLC | |||
| Indications for Use | |||
| Statement | The Southern Implants Instrument Tray is | ||
| designed to hold various dental surgical drills | |||
| and tools in order to organize, steam | |||
| sterilize, and transport the instruments | |||
| between uses. The tray is to be enclosed in | |||
| an FDA cleared steam sterilizable wrap and | |||
| sterilized in an FDA Cleared sterilizer for | |||
| one of the following cycles: | The InterActive Complete Surgical Tray is | ||
| designed to hold various dental surgical drills | |||
| and tools in order to organize, steam sterilize, | |||
| and transport the instruments between uses. | |||
| The tray is to be enclosed in an FDA cleared | |||
| steam sterilizable wrap and sterilized in an | |||
| FDA Cleared sterilizer for one of the | |||
| following cycles: | Same | ||
| Product Code | KCT | KCT | Same |
| Intended Use | Perforated instrument cassette system to hold | ||
| dental instruments in place during transport, | |||
| steam sterilization, and storage. | Perforated instrument cassette system to hold | ||
| dental instruments in place during transport, | |||
| steam sterilization, and storage. | Same | ||
| Material | |||
| Composition | Polymer Resin Radel-5000, biomedical | ||
| grade silicone, surgical grade stainless steel | Polymer Resin Radel-5000, biomedical grade | ||
| silicone | Same | ||
| Design | Plastic tray with locking lid; silicone | ||
| containment brackets and stainless-steel | |||
| holder | Plastic tray with locking lid and silicone | ||
| containment brackets | Similar | ||
| Sterilization by: |
- Gravity Steam
- Pre-vacuum
Steam 132°C
Pre-vacuum
Steam 135°C | No
Yes
Yes | Yes
Yes
No | Similar for pre-
vacuum. |
| Air Permeance | Yes | Yes | Same |
| Locking system to
hold lid in place | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Material
compatibility with
sterilization process | Yes | Yes | Same |
| Sterilant
Penetration Studies | Yes - Steam sterilization validation
conducted per ISO 17665; AAMI TIR 12 | Yes - Steam sterilization validation
conducted per AAMI / ANSO / ISO17665;
AAMI TIR 12 | Same |
| Toxicological
Properties
(biocompatibility) | Yes - Cytoxicity tests conducted as per ISO
10993-5; ISO 10993-12 | Yes - Cytoxicity tests conducted as per ISO
10993-5; ISO 10993-12 | Same |
| Transportation
Studies | Yes - Distribution studies conducted as per
ASTM D4169 | Yes - Distribution studies conducted as per
ASTM D4169 | Same |
| Cleaning
Instructions for
Reusable devices | Cleaning validations conducted as per AAMI
TIR 30, AAMI TIR 12. | Cleaning validations conducted as per AAMI
TIR 30, AAMI TIR 12. | Same |
| Material
Compatibility
(repeat validation) | Yes - Radel Technical Data Sheet | Yes - Radel Technical Data Sheet | Same |
| Drying Time | Yes - Steam sterilization validation
conducted per AAMI 17665; AAMI TIR 12 | Yes - Steam sterilization validation
conducted per AAMI 17665; AAMI TIR 12 | Same |
| Vent/Volume Ratio
in²/in³ | Large: 0.01
Medium: 0.013 - 0.014
Small: 0.014 - 0.056 | 0.184 | Different |
| Maximum
Sterilization Load
density (g/cm³) | Large: 0.533
Medium: 0.532
Small: 0.397 | 0.375 | Different |
| Dimensions (L x W
x H) (cm) | Large: 26.8 x 14.7 x 5.5
Medium: 18.7 x 13.5 x 5.5 | 19 x 14.2 x 6 | Different |
| | Small: 14.8 x 9.5 x 5.5 | | |
| Maximum weight
of tray with
instruments | Large: 752
Medium: 672
Small: 339 | 608.05 | Different |
| Maximum number
of components | Large: 25
Medium: 90
Small: 47 | 45 | Different |
Table 1: Technological Characteristics Comparison
7
The Indications for Use Statement for the subject device is similar to the primary predicate device K142519, with the difference being the name of the device
The primary predicate device K142519 is for comparison to the subject device implant designs. The subject device Southern Implants Instrument Trays have a design that similar in design to trays in K142519. The subject device is also similar to the predicate device with regards to the intended use; the material composition; sterilization method; cleaning instruction validation and toxicological properties.
PERFORMANCE DATA
Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 17665-1 | |||
| Sterilization of health | |||
| care products – moist | To verify the ability of | ||
| the sterilization process | |||
| to adequately sterilize | 6 log reduction at half | ||
| cycle | The ability for | ||
| successful sterilization | |||
| heat - part 1: | |||
| Requirements for the | |||
| development, validation | |||
| and routine control of a | |||
| sterilization process for | |||
| medical devices | the load at 132°C and | ||
| 135°C | at 132°C and 135°C | ||
| was confirmed | |||
| ISO 17664 Processing | |||
| of health care products | |||
| – information to be | |||
| provided by the medical | |||
| device manufacturer | |||
| for the processing of | |||
| medical devices | |||
| AAMI TIR 12 | |||
| Designing, testing, and | |||
| labelling reusable | |||
| medical devices for | |||
| reprocessing in health | |||
| care facilities: A guide | |||
| for medical device | |||
| manufacturers | |||
| AAMI TIR 30 A | |||
| compendium of | |||
| processes, materials, | |||
| test methods, and | |||
| acceptance criteria for | |||
| cleaning reusable | |||
| medical devices | To verify the | ||
| effectiveness of the | |||
| recommended cleaning | |||
| process. | Protein |