K Number
K231996
Device Name
Steriking® LT-Blueline Pouches with Tyvek®
Manufacturer
Date Cleared
2023-09-07

(64 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only. Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle Device lumen dimensions: Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes. Lumen Cycle: 1 lumen max for all pouch sizes. 1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm .122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm .204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm Pouch Sizes: 300 x 450 mm 250 x 400 mm
Device Description
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only. Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle Device lumen dimensions: Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes. Lumen Cycle: 1 lumen max for all pouch sizes. 1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm .122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm .204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm Pouch Sizes: 300 x 450 mm 250 x 400 mm
More Information

Not Found

Not Found

No
The device description and intended use are for sterilization pouches, which are passive containment devices and do not involve any computational or analytical functions. There is no mention of AI or ML in the provided text.

No
The device is a pouch intended for sterilizing and maintaining the sterility of other medical devices, not for direct therapeutic use on a patient.

No

Explanation: The device, Steriking® LT-Blueline Pouches with Tyvek®, is intended for enclosing other devices for sterilization and maintaining their sterility, not for diagnosing medical conditions.

No

The device described is a physical sterilization pouch, not a software application. The description focuses on the physical characteristics and intended use of the pouch for sterilization.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the pouches are for enclosing devices intended for sterilization and maintaining their sterility. This is a function related to the sterilization and storage of medical devices, not the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Description (Not Found): While the device description is not available, the intended use is the primary indicator of whether a device is an IVD.
  • Other Sections: The absence of information related to specimen handling, analysis, or diagnostic results in the other sections further supports that this is not an IVD.

IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine compatibility. This device's function is entirely focused on the sterilization and storage of other medical devices.

N/A

Intended Use / Indications for Use

Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.

Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle

Device lumen dimensions:

Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen max for all pouch sizes.

1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm

Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm

.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

Pouch Sizes: 300 x 450 mm 250 x 400 mm

Product codes

FRG

Device Description

Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization. They are designed for single use and for use in specific STERIS® V-Pro® Sterilization Cycles (Lumen Cycle, Non Lumen Cycle, Flexible Cycle) with defined device lumen dimensions and maximum weights.

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 workers

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

0

September 7, 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wipak OY % Amanda Singleton Consultant Compliance Systems International LLC 39 Lockhart Circle Amherst, New York 14228

Re: K231996

Trade/Device Name: Steriking® LT-Blueline Pouches with Tyvek® Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: August 11, 2023 Received: August 11, 2023

Dear Amanda Singleton:

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).

Sincerelv.

Eileen

Cadel

S

Digitally signed
by Eileen Cadel
-S
Date:
2023.09.07
for
13:46:02 -04'00'

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) K231996

Device Name

Steriking® LT-Blueline Pouches with Tyvek®

Indications for Use (Describe)

Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.

Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle

Device lumen dimensions:

Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen max for all pouch sizes.

1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm

Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm

.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

Pouch Sizes: 300 x 450 mm 250 x 400 mm

3

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4

September 7, 2023

Image /page/4/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Wipak OY % Amanda Singleton Consultant Compliance Systems International LLC 39 Lockhart Circle Amherst, New York 14228

Re: K231996

Trade/Device Name: Steriking® LT-Blueline Pouches with Tyvek® Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: August 11, 2023 Received: August 11, 2023

Dear Amanda Singleton:

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

5

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).

Sincerelv.

Eileen

Cadel

S

Digitally signed
by Eileen Cadel
-S
Date:
2023.09.07
for
13:46:02 -04'00'

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