(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization capabilities of a reusable instrument case, with no mention of AI or ML.
No
The device is described as a reusable sterilization container for holding surgical instruments during transport, sterilization, and surgery, not for treating any medical condition or disease.
No
The device is a reusable sterilization container used for transporting, sterilizing, and holding medical devices, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of stainless steel, silicone, and thermoplastic resin, indicating it is a hardware device. The performance studies also focus on sterilization validation and cleaning, which are relevant to a physical container, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of this device is for containing reusable medical devices (surgical instruments) during transport, sterilization, and surgery. It is used in a surgical and reprocessing environment.
- Device Description: The device is a reusable sterilization container made of stainless steel and other materials, designed to hold instruments.
- Lack of Biological Sample Interaction: The device does not interact with biological samples from a patient for diagnostic purposes. Its function is to facilitate the sterilization and handling of surgical instruments.
Therefore, this device falls under the category of a medical device used in the surgical and reprocessing workflow, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.
The product shall only be used:
- · in a controlled surgical environment under sterile conditions such as a hospital,
- · in reprocessing environment at sterilization departments or reprocessing centers,
- · and for transport of surgical instruments.
Sterilization parameters:
In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country
The worse-case validated load for the Instrument Case, including instruments, is 1700 g.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Instrument case, Figure 1, is a reusable sterilization container intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. The specific use for the Instrument case is to hold reusable instruments during transport, the sterilization process, and during surgery.
The Instrument case consists of tray and lid made of stainless steel with a small box included, which is a component tray. The grommets, strips and holders that keep the instruments in place are made of silicone or stainless steel, and the latches in the lid are made of a Thermoplastic resin, Santoprene. The packaging materials are made of polyethylene and polyolefin.
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
staff involved in reprocessing of reusable instruments, and for surgical teams.
controlled surgical environment under sterile conditions such as a hospital,
reprocessing environment at sterilization departments or reprocessing centers,
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 to demonstrate substantial equivalence to the predicate device, the Instrument Case (K223672). The predicate device and the subject device are identical, except for additional etchings. Substantial equivalence to the predicate device was accomplished through non-clinical data related to sterilization validation. The results demonstrate the Instrument Case is substantially equivalent to the predicate device. The changes do not affect the safety and performance of the Instrument Case.
Table 2 identifies the performance data for the subject device, and all of the testing yielded PASS results. For the sterilization validation, two instruments were added for sterility testing of the subject device, and for the remaining performance data, the test results of the predicate device remained valid for the subject device. The performance data shows that the subject device is as safe and effective as the predicate device.
Automated cleaning (with enzymatic detergent)
Test Methodology: AAMI TIR12:2010 AAMI TIR30:2011
Test Description: 6 simulated use cycles 5 accumulation cycles 3 efficacy cycles Visual inspection for any residual test soil, residual protein and hemoglobin levels and cytotoxicity testing for presence of detergent residuals.
Acceptance Criteria: No visible soil should remain on the test articles. Protein level should be 1)
Results: PASS. The semi-volatile and inorganic substances that were detected and that were of toxicological concern had a MOS>1
Biocompatibility
Test Methodology: ISO 10993-5; 2009
Test Description: Cytotoxicity
Acceptance Criteria: Non-Cytotoxic
Results: PASS. The instrument case is not cytotoxic
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
§ 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
August 24, 2023
Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cochlear Americas Whitney Alexander Regulatory Affairs Specialist II 10350 Park Meadows Drive Lone Tree. Colorado 80124
Re: K231604
Trade/Device Name: Instrument Case Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 27, 2023 Received: July 27, 2023
Dear Whitney Alexander:
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.
Digitally signed
by Eileen Cadel
-S
Eileen
Cadel -S Date:
2023.08.24
11:39:02 -04'00'
for
Colin O'Neill, M.B.E.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231604
Device Name Instrument Case
Indications for Use (Describe)
The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.
The product shall only be used:
- · in a controlled surgical environment under sterile conditions such as a hospital,
- · in reprocessing environment at sterilization departments or reprocessing centers,
- · and for transport of surgical instruments.
Sterilization parameters:
In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country
The worse-case validated load for the Instrument Case, including instruments, is 1700 g.
| 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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3
Image /page/3/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes in a golden color, arranged in a way that resembles an ear or sound waves. Below the curved shapes, the company name "Cochlear" is written in a matching golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, also in golden color.
510(k) Summary
| A. Submitter Information
Submitted by: | Cochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| On behalf of the manufacturer: | Cochlear Bone Anchored Solutions AB
Konstruktionsvägen 14,
SE-435 33 Mölnlycke
Sweden
(Establishment Number 9616024) |
| Contact: | Whitney Alexander
Regulatory Affairs Specialist II
Cochlear Americas
C: 719-337-8620
E: walexander@cochlear.com |
| B. Date Prepared | 21-August-2023 |
| C. Device Name and Classification | Instrument Case |
| Device Names:
Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories
21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |
| D. Predicate Device
Device Names: | Instrument Case |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories
21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |
510(k): K223672
4
Image /page/4/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized representation of a cochlea, the spiral-shaped part of the inner ear, rendered in a golden color. Below the cochlea graphic, the company name "Cochlear" is written in a matching golden font. Underneath the company name is the tagline "Hear now. And always".
E. Purpose of Submission
This Special 510(k) seeks clearance for an updated Instrument Case that is intended to hold reusable instruments used during surgical procedures for Osia® and Baha® bone conduction implants. Outside of surgery, the Instrument Case is designed to hold the reusable instruments during the sterilization process and for transportation of the instruments.
F. Device Description
The Instrument case, Figure 1, is a reusable sterilization container intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. The specific use for the Instrument case is to hold reusable instruments during transport, the sterilization process, and during surgery.
The Instrument case consists of tray and lid made of stainless steel with a small box included, which is a component tray. The grommets, strips and holders that keep the instruments in place are made of silicone or stainless steel, and the latches in the lid are made of a Thermoplastic resin, Santoprene. The packaging materials are made of polyethylene and polyolefin.
Figure 1: Instrument Case
G. Intended Use
The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery.
H. Indications for Use
The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for
surgical teams.
5
Image /page/5/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three stylized, overlapping "C" shapes in a golden color, arranged in a way that suggests sound waves or a spiral. Below the symbol, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the name, the tagline "Hear now. And always" is displayed in a smaller, lighter font, emphasizing the company's commitment to long-term hearing solutions.
The product shall only be used:
- in a controlled surgical environment under sterile conditions such as a hospital, .
- in reprocessing environment at sterilization departments or reprocessing centers, .
- and for transport of surgical instruments.
Sterilization parameters:
In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country
The worse-case validated load for the Instrument Case, including instruments, is 1700 g.
I. Technological Characteristics and Comparison to Predicate
Table 1 summarizes a comparison of the technological characteristics of the currently available Instrument Case (predicate device) with the updated Instrument Case (subject device).
| Feature | Instrument Case (Subject Device) | Instrument Case (Predicate Device, K223672) | Comparison Notes |
|---|---|---|---|
| Manufacturer | Cochlear | Cochlear | Same |
| Class | II | II | Same |
| Product Code | KCT | KCT | Same |
| Intended Use | The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery. | The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery. | Same |
| Indications for Use | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. | ||
| The product shall only be used: | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. | ||
| The product shall only be used: | Similar. Minor sentence added to support global distribution of the device. The difference does not affect the safety and performance of | ||
| Feature | Instrument Case (Subject | ||
| Device) | Instrument Case | ||
| (Predicate Device, | |||
| K223672) | Comparison | ||
| Notes | |||
| • in a controlled surgical | |||
| environment under sterile | |||
| conditions such as a hospital, | |||
| • in reprocessing environment | |||
| at sterilization departments or | |||
| reprocessing centers, | |||
| • and for transport of surgical | |||
| instruments. | |||
| Sterilization parameters: | |||
| In US: Pre-Vacuum Steam at | |||
| $132$ °C ( $270$ °F) for 4 min | |||
| with a 20 minutes dry time | |||
| Outside US: See the | |||
| Reprocessing Guide available | |||
| in your country | |||
| The worst-case validated load | |||
| for the Instrument Case, | |||
| including instruments, is 1700 | |||
| g. | • in a controlled | ||
| surgical environment | |||
| under sterile conditions | |||
| such as a hospital, | |||
| • in reprocessing | |||
| environment at | |||
| sterilization | |||
| departments or | |||
| reprocessing centers, | |||
| • and for transport of | |||
| surgical instruments. | |||
| Sterilization | |||
| parameters: | |||
| Pre-Vacuum Steam at | |||
| $132$ °C ( $270$ °F) for 4 | |||
| min with a 20 minutes | |||
| dry time | |||
| The worst-case | |||
| validated load for the | |||
| Instrument Case, | |||
| including instruments, | |||
| is 1700 g. | the subject | ||
| device. | |||
| General Design | Stainless steel instrument tray | ||
| with a stainless steel locking | |||
| lid and removable stainless | |||
| steel component tray. Silicone | |||
| instrument holders. | Stainless steel | ||
| instrument tray with a | |||
| stainless steel locking | |||
| lid and removable | |||
| stainless steel | |||
| component tray. | |||
| Silicone instrument | |||
| holders. | Same, the | ||
| subject device | |||
| only differs | |||
| with a few | |||
| additional | |||
| device | |||
| etchings. | |||
| Dimensions | Length x Width x Height, mm | ||
| $265$ x $160$ x $42$ | Length x Width x | ||
| Height, mm | |||
| $265$ x $160$ x $42$ | Same | ||
| Materials | Base Tray - Stainless steel | ||
| Lid - Stainless steel | |||
| Case tray - Stainless steel | |||
| Tooling Support – Silicone | Base Tray - Stainless | ||
| steel | |||
| Lid - Stainless steel | |||
| Case tray - Stainless | |||
| steel | |||
| Tooling Support – Silicone | Same | ||
| Feature | Instrument Case (Subject Device) | Instrument Case (Predicate Device, K223672) | Comparison Notes |
| Tooling Support – Silicone | |||
| Sterility | Non-sterile | Non-sterile | Same |
| Sterilization Method | Dynamic air removal steam sterilization (prevacuum) to a Sterility Assurance Level (SAL) of ≤10-6 | Dynamic air removal steam sterilization (prevacuum) to a Sterility Assurance Level (SAL) of ≤10-6 | Same |
| Sterilization Parameters | 132°C for 4 minutes with a 20 minutes drying time | 132°C for 4 minutes with a 20 minutes drying time | Same |
| Reusable | Yes | Yes | Same |
| Useful Life | 25 Cycles | 25 Cycles | Same |
| Biocompatibility | Planning and testing have been carried out according to ISO 10993-1. | ||
| The Instrument Case is biocompatible due to the testing with pass results. | Planning and testing have been carried out according to ISO 10993-1. | ||
| The Instrument Case is biocompatible due to the testing with pass results. | Same | ||
| Perforated | Yes | Yes | Same |
| Sterile Barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Maximum Load for Sterilization | 1700g | 1700g | Same |
| Compatible Reusable Instruments | Cochlear's bone-anchored reusable instrument portfolio and Elos Pinol's C9866 Multi wrench and C10110 Square adapter for Multi wrench | Cochlear's bone-anchored reusable instrument portfolio | Similar – Additional instrumentation validated for sterilization within Cochlear's instrument case |
Table 1: Technological Characteristics Comparison
6
Image /page/6/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape above the company name. Below the name, the tagline "Hear now. And always" is written in a smaller, complementary font.
7
Image /page/7/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the part of the inner ear responsible for hearing. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always.", which conveys the company's commitment to providing long-term hearing solutions.
J. Performance Data
Bench testing was conducted to demonstrate substantial equivalence to the predicate device, the Instrument Case (K223672). The predicate device and the subject device are identical, except for additional etchings. Substantial equivalence to the predicate device was accomplished through non-clinical data related to sterilization validation. The results demonstrate the Instrument Case
8
Image /page/8/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the auditory portion of the inner ear. Below the spiral is the company name, "Cochlear," also in golden-yellow, with the registered trademark symbol. Underneath the company name is the tagline, "Hear now. And always."
is substantially equivalent to the predicate device. The changes do not affect the safety and performance of the Instrument Case.
Table 2 identifies the performance data for the subject device, and all of the testing yielded PASS results. For the sterilization validation, two instruments were added for sterility testing of the subject device, and for the remaining performance data, the test results of the predicate device remained valid for the subject device. The performance data shows that the subject device is as safe and effective as the predicate device.
| Test | Test
Methodology | Test Description | Acceptance
Criteria | Results | Comparison |
|--------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Automated
cleaning (with
enzymatic
detergent) | AAMI
TIR12:2010
AAMI
TIR30:2011 | 6 simulated use cycles 5 accumulation cycles 3 efficacy cycles Visual inspection for any residual
test soil, residual protein and
hemoglobin levels and cytotoxicity
testing for presence of
detergent residuals. | No visible soil should
remain on the test
articles.
Protein level should be
-
| PASS. The
semi-volatile
and
inorganic
substances
that were
detected and
that were of
toxicological
concern had
a MOS>1 | Same. Test
results of
predicate
device
remain valid
for subject
device. |
| Biocompatibility | ISO 10993-5;
2009 | Cytotoxicity | Non-
Cytotoxic | PASS. The
instrument
case is not
cytotoxic | Same. Test
results of
predicate
device
remain valid
for subject
device. |
10
Image /page/10/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals, positioned above the company name. Below the name "Cochlear" is the tagline "Hear now. And always" in a smaller, lighter font, emphasizing the company's commitment to providing long-term hearing support.
11
Image /page/11/Picture/0 description: The image is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow seashell-like symbol at the top. Below the symbol is the company name, "Cochlear," also in golden-yellow. Underneath the company name is the tagline, "Hear now. And always" in a smaller, lighter font.
K. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K223672.