(19 days)
Unknown
The summary mentions using "proprietary and off-the-shelf software" with patient imaging to design a patient-specific implant. While this involves image processing and potentially complex algorithms, there is no explicit mention or indication that AI or ML techniques are specifically employed in this process. The description focuses on the physical components and surgical instruments, not the software's underlying technology.
Yes
The device is a knee replacement system intended for use in patients with knee joint pain and disability due to various conditions like osteoarthritis, trauma, rheumatoid arthritis, or osteonecrosis, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This document describes a knee replacement system (implantable prosthetic device) and associated surgical instruments, not a device used for diagnosis.
No
The device description clearly states that the system includes physical components such as femoral, tibial, and patellar implants made of various alloys and polymers, as well as surgical instruments. While software is used in the design process, the device itself is a physical implant system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee replacement system (femoral, tibial, patellar components, etc.) and the materials they are made from. This aligns with a surgical implant.
- No mention of in vitro testing: The text does not describe any process of analyzing samples (blood, tissue, etc.) outside of the body to diagnose a condition or provide information about a patient's health status.
- Focus on surgical procedure: The mention of surgical instruments and guiding bone cutting further reinforces its role in a surgical procedure.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to treat a condition through surgery.
N/A
Intended Use / Indications for Use
The iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
iTotal Identity® Posterior Stabilized (PS) Knee Replacement System
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY, OOG
Device Description
iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System (KRS) are patient specific tri-compartmental faceted knee replacements systems. The iTotal Identity CR KRS is a faceted posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. iTotal Identity® PS KRS is a semi-constrained, cemented knee implant consisting of femoral, tibial, patellar and articular tibial insert components.
Using patient imaging and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel (stem) cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two piece is available with the CR KRS only). The polyethylene inserts may be manufactured from either UHMWPE (iPoly®) or iPoly® XE (a highly cross-linked vitamin E stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.
For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity® CR KRS or iTotal Identity® PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging scans
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed including sterilization and risk-based biocompatibility testing. The results support that the device components are effectively sterilized using VHP LTS-V. Testing includes: Sterilization Validation testing to establish a SAL of 1x10-6 VHP Residual Testing. The testing results conclude that the addition of the use of VHP LTS-V sterilization raises no new issues regarding safety or effectiveness. The performance of the subject devices sterilized by VHP LTS-V is expected to be the same as the currently marketed predicate devices.
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.
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
February 17, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Conformis Inc. Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive, 4th Floor Billerica. Massachusetts 01821
Re: K210252
Trade/Device Name: iTotal Identity® Cruciate Retaining (CR) Knee Replacement System, iTotal Identity® Posterior Stabilizing (PS) Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OIY. OOG Dated: January 25, 2021 Received: January 29, 2021
Dear Mary Kruitwagen:
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
1
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 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,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
iTotal Identity Cruciate Retaining (CR) Knee Replacement System
Indications for Use (Describe)
The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a replatent in pations with rate join of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
-
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
-
Post traumatic loss of joint function.
-
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate finction and stability.
-
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
-
Revision procedures provided that analy landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is for cemented use only.
| 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) |
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 i ne burden instructions, search existing data sources, gather and maintain the data needed and complete tirrie to review instruction. Send comments regarding this burden estimate or any other aspect aft 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
Indications for Use
510(k) Number (if known)
Device Name
iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
Indications for Use (Describe)
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint I rie 1 olar 1 5 Kince Replacement be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include:
-
Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
-
Post traumatic loss of joint function.
-
Moderate varus, valgus or flexion deformity.
-
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
-
Revision procedures provided that and only landmarks necessary for alignment and positioning of the implant are
identifiable on patient imaging scans.
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)
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 I he burden instructions, search existing data sources, gather and maintain the data needed and complete time to review instruction. 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."
page 350 of 127
4
510(K) Summary
| Subject Device: (Proprietary/Trade
name): | iTotal Identity® Cruciate Retaining (CR) Knee Replacement System
iTotal Identity® Posterior Stabilized (PS) Knee Replacement
System |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Usual Name: | Knee Replacement System |
| Type of Submission: | Special 510(k) |
| Device Class: | II |
| Regulation Number: | 888.3560 |
| Regulation Description: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Primary Product Classification
(Product Code) and Description: | JWH
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Secondary Product Classifications
(Product Code) and Descriptions: | OOG, OIY
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Reviewing Agency: | Orthopedics |
| Date of Summary Preparation: | January 27, 2021 |
| Submitter's Name and Address: | Conformis Inc.
600 Technology Park Drive
Fourth Floor
Billerica, MA 01821
USA |
| Telephone Number: | 781-345-9001 |
| Establishment Registration
Number(s): | 3009844603
3004153240 |
| Contact Name: | Mary Kruitwagen |
| Contact Telephone: | 781-345-9038 |
| Contact email: | Mary.Kruitwagen@conformis.com |
| Alternate Contact: | Kara Johnson |
| Alternate Contact Telephone: | 781-832-5402 |
| Alternate Contact email: | Kara.Johnson@conformis.com |
| Primary Predicate Device: | iTotal Identity® Cruciate Retaining (CR) Knee Replacement System
iTotal Identity® Posterior Stabilized (PS) Knee Replacement
System |
| Primary Predicate Device 510(k): | K203447; December 22, 2020 |
| Primary Predicate Device Product
Classification (ProCode) and
Description: | JWH, OOG, OIY
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Secondary Predicate Device: | iUni Unicondylar Knee Replacement System, iDuo
Bicompartmental Knee Repair System, iTotal CR Knee
Replacement System, iTotal PS Knee Replacement System |
| Secondary Predicate Device 510(k): | K193105; March 13, 2020 |
| Secondary Predicate Device
Classification (ProCode) and
Description: | JWH, OOG, OIY, NPJ, HSX
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Modification | This submission is to seek clearance for use of an additional sterilization process
for the subject devices iTotal Identity® Cruciate Retaining (CR) Knee
Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee
Replacement System. This submission seeks to add Vaporized Hydrogen
Peroxide Low-Temperature Sterilant-Vacuum (VHP LTS-V) to the portfolio of
sterilization processes for the subject devices. There are no device
modifications. |
| Device Description | iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) and
iTotal Identity® Posterior Stabilized (PS) Knee Replacement System (KRS) are
patient specific tri-compartmental faceted knee replacements systems. The
iTotal Identity CR KRS is a faceted posterior cruciate ligament retaining knee
replacement system. It is a semi-constrained, cemented knee implant which
consists of femoral, tibial, and patellar components. iTotal Identity® PS KRS is a
semi-constrained, cemented knee implant consisting of femoral, tibial, patellar
and articular tibial insert components.
Using patient imaging and a combination of proprietary and off-the-shelf
software, a patient-specific implant is designed that best meets the geometric
and anatomic requirements of the specific patient. The femoral component is
manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial
component includes a metal tray and tray keel stem extension manufactured
from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel (stem) cap manufactured
from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two
piece is available with the CR KRS only). The polyethylene inserts may be
manufactured from either UHMWPE (iPoly®) or iPoly® XE (a highly cross-linked
vitamin E stabilized UHMWPE). The patellar component is provided in either a
round or oval dome shape and may be manufactured from either UHMWPE or
iPoly® XE.
For user convenience, single-use, patient-specific ancillary orthopedic manual
surgical instruments designed for use with the proposed iTotal Identity® CR KRS
or iTotal Identity® PS KRS are provided to assist in the positioning of the total
knee replacement components intraoperatively and in guiding the cutting of
bone. In addition, reusable orthopedic manual surgical instruments are
provided separately. |
| Indications for Use | iTotal Identity® Cruciate Retaining (CR) Knee Replacement System
The iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) is
intended for use as a total knee replacement in patients with knee joint pain |
5
6
and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
iTotal Identity® Posterior Stabilized (PS) Knee Replacement System
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
Technological Characteristics
The proposed and predicate devices are cemented knee implants that consist of three primary components; femoral, tibial, and patellar implants. Single-use, patient-specific ancillary surgical instruments are provided for use to assist with surgical implantation. Reusable ancillary surgical instruments, provided in a reusable instrument tray, assist with surgical implantation.
The subject devices iTotal Identity Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System are the same as the predicate devices with regards to:
- Indications for Use
- Device design
7
| Device usage Operating principles Packaging Sterilization processes (methods) Biocompatibility Shelf-life Materials of composition The modification is to add an additional sterilization process (method) for the subject devices. There are no design changes to the subject device beyond the added sterilization process. The manufacture of the subject device is unchanged from that described in the 510(k) submissions of the predicate devices. | |
|---|---|
| Performance Data | Non-clinical testing was performed including sterilization and risk-based biocompatibility testing. The results support that the device components are effectively sterilized using VHP LTS-V. Testing includes: Sterilization Validation testing to establish a SAL of 1x10-6 VHP Residual Testing |
| The testing results conclude that the addition of the use of VHP LTS-V sterilization raises no new issues regarding safety or effectiveness. The performance of the subject devices sterilized by VHP LTS-V is expected to be the same as the currently marketed predicate devices. | |
| Substantial | |
| Equivalence | The modification to add an additional sterilization process shows equivalency to the VHP LTS-V sterilization as described in the secondary predicate. Results support that the VHP LTS-V sterilized subject devices would be equivalent to the primary predicate devices using currently cleared sterilization processes (EO, VHP gas plasma). No new issues of safety and effectiveness were raised. |
| Conclusion | Based on the results of the testing performed, the subject iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System, are substantially equivalent to the predicate devices iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System and can be sterilized to a SAL of 1x10-6 utilizing VHP LTS-V sterilization. |