(338 days)
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.
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
The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 17665-1 (Sterilization of health care products – moist heat) | To verify the ability of the sterilization process to adequately sterilize the load at 132°C and 135°C | 6 log reduction at half cycle | The ability for successful sterilization at 132°C and 135°C was confirmed. |
| ISO 17664 / AAMI TIR 12 / AAMI TIR 30 (Cleaning effectiveness) | To verify the effectiveness of the recommended cleaning process. | Protein < 6 µg/ml Hemoglobin < 100 mg/ml | The recommended cleaning process is effective. |
| ISO 10993-5 (Biological Evaluation of Medical Device – part 5: Tests for in-vitro cytotoxicity) | To observe the cytotoxicity potential of the device | Morphological grade 2 | No cytotoxicity potential was observed. |
| ASTM D 4169 (2007) (Standard practice for performance testing of shipping containers and systems) | To verify the durability of the device during transportation. | No damage to the tray. | The instrument trays survived transit and transport conditions. |
| Temperature distribution control | To verify the homogeneity of the temperature distribution inside the tray | There must be no areas colder than the specified temperature | Temperature was homogenous. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each test set. It mentions "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)." This implies testing was done on these configurations, but not specific sample numbers for individual tests. The data provenance (country of origin, retrospective/prospective) is not specified.
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 the type of device and tests described. The "ground truth" here relates to objective performance criteria for sterilization, cleaning, biocompatibility, and physical durability, which are assessed through laboratory testing against established standards, not through expert human interpretation of medical images or conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 consensus are typically used for subjectively assessed data, such as in clinical trials or image interpretation. This is not mentioned and is not applicable to the engineering and biological performance tests described here.
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
An MRMC comparative effectiveness study is not relevant to this device. This type of study applies to diagnostic AI devices involving human readers. The Southern Implants Instrument Trays are physical medical devices for sterilization and organization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm alone. The device in question is a physical instrument tray, not an AI algorithm. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on:
- Established scientific principles and standards: For sterilization effectiveness (6 log reduction), cleaning efficacy (protein and hemoglobin levels), cytotoxicity (morphological grade), and physical durability (no damage).
- Standardized test methods: Such as ISO 17665-1, ISO 17664, AAMI TIR 12, AAMI TIR 30, ISO 10993-5, and ASTM D 4169.
- Measurement of physical and biological parameters: e.g., bacterial reduction, chemical residue levels, cell viability, physical integrity, temperature readings.
8. The sample size for the training set
This device is not an AI algorithm that requires a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
This question is not applicable as there is no AI training set for this device.
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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
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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
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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 ofInstruments | Weight ofTray (g) | Weight ofFull Tray (g) | Vent to VolumeRatio (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) |
| Medium18.7 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) | |
| Small14.8 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)
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510(k) Summary
Southern Implants Instrument Trays
28/02/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd1 Albert RoadIrene, Gauteng, 0062 South AfricaTelephone: +27 12 667 1046Fax: +27 12 667 1029 |
|---|---|
| Official Contact | Leith CummingActing Head of Regulatory Affairs and QualityEmail: 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 otherAccessories |
| Classification Regulation | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification PanelReviewing Branch | General HospitalGeneral Hospital |
PREDICATE DEVICE INFORMATION The primary predicate device is K142519 The reference device is K182865.
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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) | ProductCode | Number ofInstruments | Weight ofTray (g) | Weight ofFull Tray (g) | Vent to VolumeRatio (in²/in³) | For Use With |
|---|---|---|---|---|---|---|
| Large26.8 x 14.7 x5.5 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) | |
| Medium18.7 x 13.5 x5.5 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) | |
| Small14.8 x 9.5 x5.5 cm | I-PROS-EG | 25 | 180.5 | 280 | 0.014 | Abutments (K003620;K020617; K033171;K052490; K053478; |
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| 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.
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| Subject Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| Comparison | Instrument TraysSouthern Implants (Pty) Ltd | K142519InterActive Complete Surgical TrayImplant Direct Sybron ManufacturingLLC | |
| Indications for UseStatement | The Southern Implants Instrument Tray isdesigned to hold various dental surgical drillsand tools in order to organize, steamsterilize, and transport the instrumentsbetween uses. The tray is to be enclosed inan FDA cleared steam sterilizable wrap andsterilized in an FDA Cleared sterilizer forone of the following cycles: | The InterActive Complete Surgical Tray isdesigned to hold various dental surgical drillsand tools in order to organize, steam sterilize,and transport the instruments between uses.The tray is to be enclosed in an FDA clearedsteam sterilizable wrap and sterilized in anFDA Cleared sterilizer for one of thefollowing cycles: | Same |
| Product Code | KCT | KCT | Same |
| Intended Use | Perforated instrument cassette system to holddental instruments in place during transport,steam sterilization, and storage. | Perforated instrument cassette system to holddental instruments in place during transport,steam sterilization, and storage. | Same |
| MaterialComposition | Polymer Resin Radel-5000, biomedicalgrade silicone, surgical grade stainless steel | Polymer Resin Radel-5000, biomedical gradesilicone | Same |
| Design | Plastic tray with locking lid; siliconecontainment brackets and stainless-steelholder | Plastic tray with locking lid and siliconecontainment brackets | Similar |
| Sterilization by:1. Gravity Steam2. Pre-vacuumSteam 132°CPre-vacuumSteam 135°C | NoYesYes | YesYesNo | Similar for pre-vacuum. |
| Air Permeance | Yes | Yes | Same |
| Locking system tohold lid in place | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Materialcompatibility withsterilization process | Yes | Yes | Same |
| SterilantPenetration Studies | Yes - Steam sterilization validationconducted per ISO 17665; AAMI TIR 12 | Yes - Steam sterilization validationconducted per AAMI / ANSO / ISO17665;AAMI TIR 12 | Same |
| ToxicologicalProperties(biocompatibility) | Yes - Cytoxicity tests conducted as per ISO10993-5; ISO 10993-12 | Yes - Cytoxicity tests conducted as per ISO10993-5; ISO 10993-12 | Same |
| TransportationStudies | Yes - Distribution studies conducted as perASTM D4169 | Yes - Distribution studies conducted as perASTM D4169 | Same |
| CleaningInstructions forReusable devices | Cleaning validations conducted as per AAMITIR 30, AAMI TIR 12. | Cleaning validations conducted as per AAMITIR 30, AAMI TIR 12. | Same |
| MaterialCompatibility(repeat validation) | Yes - Radel Technical Data Sheet | Yes - Radel Technical Data Sheet | Same |
| Drying Time | Yes - Steam sterilization validationconducted per AAMI 17665; AAMI TIR 12 | Yes - Steam sterilization validationconducted per AAMI 17665; AAMI TIR 12 | Same |
| Vent/Volume Ratioin²/in³ | Large: 0.01Medium: 0.013 - 0.014Small: 0.014 - 0.056 | 0.184 | Different |
| MaximumSterilization Loaddensity (g/cm³) | Large: 0.533Medium: 0.532Small: 0.397 | 0.375 | Different |
| Dimensions (L x Wx H) (cm) | Large: 26.8 x 14.7 x 5.5Medium: 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 weightof tray withinstruments | Large: 752Medium: 672Small: 339 | 608.05 | Different |
| Maximum numberof components | Large: 25Medium: 90Small: 47 | 45 | Different |
Table 1: Technological Characteristics Comparison
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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 17665-1Sterilization of healthcare products – moist | To verify the ability ofthe sterilization processto adequately sterilize | 6 log reduction at halfcycle | The ability forsuccessful sterilization |
| heat - part 1:Requirements for thedevelopment, validationand routine control of asterilization process formedical devices | the load at 132°C and135°C | at 132°C and 135°Cwas confirmed | |
| ISO 17664 Processingof health care products– information to beprovided by the medicaldevice manufacturerfor the processing ofmedical devicesAAMI TIR 12Designing, testing, andlabelling reusablemedical devices forreprocessing in healthcare facilities: A guidefor medical devicemanufacturersAAMI TIR 30 Acompendium ofprocesses, materials,test methods, andacceptance criteria forcleaning reusablemedical devices | To verify theeffectiveness of therecommended cleaningprocess. | Protein < 6 µg/mlHemoglobin < 100 mg/ml | The recommendedcleaning process iseffective. |
| ISO 10993-5 BiologicalEvaluation of MedicalDevice – part 5: Testsfor in-vitro cytotoxicity | To observe thecytotoxicity potential ofthe device | Morphological grade 2 | No cytotoxicitypotential was observed. |
| ASTM D 4169 (2007)Standard practice forperformance testing ofshipping containersand systems | To verify the durabilityof the device duringtransportation. | No damage to the tray. | The instrument trayssurvived transit andtransport conditions. |
| Temperaturedistribution control | To verify thehomogeneity of thetemperature distributioninside the tray | There must be no areascolder than thespecified temperature | Temperature washomogenous. |
Table 2: Summary of Non-Clinical Testing
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CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the Southern Implants Instrument Trays are as safe, as effective and performs as well as or better than the legally marketed device K142519 InterActive Complete Surgical tray.
§ 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).