Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a sterilization pouch and its physical performance characteristics, with no mention of AI or ML.

Therapeutic

No
The device is a sterilization pouch used to maintain the sterility of other medical devices, not to directly treat or diagnose a medical condition.

Diagnostic

No

The device is a sterilization pouch used to enclose and maintain the sterility of other medical devices, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical pouch made of Tyvek and plastic film, intended for containing medical devices during sterilization and maintaining sterility. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Perpak™ Sterilization Tyvek Pouch is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the sterilization and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
Device Description: The description reinforces the role of containing and maintaining sterility of medical devices during and after sterilization.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the Perpak™ Sterilization Tyvek Pouch falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

Product codes (comma separated list FDA assigned to the subject device)

FRG

Device Description

The Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.

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)

The following performance and shelf-life tests were performed and the test results passed the pre-set criteria, supporting the substantial equivalence to the predicate devices.

Dye penetration Test (Seal Integrity Test): No leaks - Pass
Seal Peel Test: > 0.6kg.f - Pass
Thickness Variations: Film : 70 ± 10μm (0.07 ± 0.01mm) Tyvek : 89~282 μm (0.089 ~ 0.282 mm) - Pass
Tensile strength of Tyvek®: Tensile strength: Spec > 117 N Elongation : Spec > 10% - Pass
Tensile strength of plastic film: 1) Spec > 300 kg.f/cm2 2) Elongation : Spec > 50 % - Pass
Burst Strength: > 1kg.f/ cm2 - Pass
Tear Resistance of Tyvek: MD: Spec > 3,400m N TD: Spec > 2,000mN - Pass
Tear Resistance of plastic film: MD: Spec > 260m N TD: Spec > 170mN - Pass
Microbial Barrier: Log Reduction Value ≥4,≥99.99% - Pass
Sterilant penetration test of the Perpak Sterilization Tyvek Pouch. Roll using the half-cycle validation of the LOWTEM Crystal 120 Sterilizer: All Negative - Pass
Microbial Barrier, Packaging Integrity performance of the Perpak Sterilization Tyvek Pouch, Roll: All processed Cycle tapes, CI strips and SCBI exhibited complete color change and all processed SCBIs were negative for growth. - Pass
Sterility test for medical devices packaged with KM Perpak pouch- LOWTEM: Medical devices packaged in KM PerpakTM sterilization pouches after LOWTEM Crystal 120 sterilization cycle have been verified to maintain the sterility - Pass

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.

K180672

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 18, 2024

KM Corp. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Kannan Ave. STE 160 Irvine. California 92612

Re: K241123

Trade/Device Name: Perpak™ Sterilization Tyvek Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: September 2, 2024 Received: September 3, 2024

Dear Priscilla Chung:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

2

Sincerely, Christopher K. Dugard -2

Christopher K. Dugard, M.S. Assistant Director THT4C1: Sterility Devices Team DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241123

Device Name Perpak™ Sterilization Tyvek Pouch

Indications for Use (Describe)

The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

Specifications

Type	Model name	Dimensions	Max load (Each material)
			Metal (g)	Plastic (g)
Sterilization
Pouch Flat	AOB00402	150mm×600mm	170	360
	AOB00164	100mm×350mm	70	10
	AOB00163	150mm×700mm	190	370
	AOB00162	150mm×550mm	130	300
	AOB00161	150mm×450mm	80	160
Sterilization Roll
Flat	AOA00017	400mm×200M	155	355
	AOA00016	300mm×200M	140	340
	AOA00015	250mm×200M	100	330
	AOA00014	200mm×200M	100	310
	AOA00013	150mm×200M	80	160
	AOA00012	100mm×200M	70	10
	AOA00011	75mm×200M	50	10

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)

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4

510(k) Summary

(K241123)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 09/2/2024

1. Submitter/Applicant

KM Corp. 23-21, Nonggongdanji-gil, Pyeongchang-eup, Pyeongchang-gun, Gangwon-do, Republic of Korea Tel.: +82-31-218-8037 Fax: +82-31-218-8040 Email: info@kmbiz.com

U.S Agent/Contact Person 2.

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: Perpak™ Sterilization Tyvek Pouch Common Name: Sterilization Wrap Classification: Class II Classification regulation: 21 CFR 880.6850 Product Code: FRG

4. Predicate Devices:

Sterilization Pouch/Roll Made with Tyvek® by SIGMA Medical Supplies Corp.(K180672)

Device Description: ട്.

The Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.

5

Indication for use: 6.

The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

Type	Model name	Dimensions	Max load (Each material)
			Metal (g)	Plastic (g)
Sterilization
Pouch Flat	AOB00402	150mm×600mm	170	360
	AOB00164	100mm×350mm	70	10
	AOB00163	150mm×700mm	190	370
	AOB00162	150mm×550mm	130	300
	AOB00161	150mm×450mm	80	160
Sterilization Roll
Flat	AOA00017	400mm×200M	155	355
	AOA00016	300mm×200M	140	340
	AOA00015	250mm×200M	100	330
	AOA00014	200mm×200M	100	310
	AOA00013	150mm×200M	80	160
	AOA00012	100mm×200M	70	10
	AOA00011	75mm×200M	50	10

Specifications

7. Performance Tests

The following performance and shelf-life tests were performed and the test results passed the pre-set criteria, supporting the substantial equivalence to the predicate devices.

Test Method	Purpose	Acceptance Criteria	Results
ASTM F 1929;
ISO 11607-1	Dye penetration Test
(Seal Integrity Test)	No leaks	Pass
ASTM F88/F88M;
ISO 11607-1	Seal Peel Test	> 0.6kg.f	Pass
ASTM F 2251	Thickness Variations	Film : 70 ± 10II $ \mu m $
(0.07 ± 0.01mm)
Tyvek : 89~282 $ \mu m $
(0.089 ~ 0.282 mm)	Pass
ASTM D 503	Tensile strength of
Tyvek®	Tensile strength: Spec > 117 N
Elongation : Spec > 10%	Pass
ASTM D882	Tensile strength of plastic
film	1) Spec > 300 kg.f/cm $^2$

Elongation : Spec > 50 % | Pass |
| ASTM F1140 | Burst Strength | > 1kg.f/ cm $^2$ | Pass |

6

| ASTM D1922 | Tear Resistance of Tyvek | MD: Spec > 3,400m N
TD: Spec > 2,000mN | Pass |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ASTM D1922 | Tear Resistance of plastic
film | MD: Spec > 260m N
TD: Spec > 170mN | Pass |
| ASTM F1608 | Microbial Barrier | Log Reduction Value
≥4,≥99.99% | Pass |
| Sterilant penetration test | Sterilant penetration test
of the Perpak Sterilization
Tyvek Pouch. Roll using
the half-cycle validation
of the LOWTEM Crystal
120 Sterilizer | All Negative | Pass |
| Microbial Barrier,
Packaging Integrity | Microbial Barrier,
Packaging Integrity
performance of the Perpak
Sterilization Tyvek Pouch,
Roll | All processed Cycle tapes, CI strips
and SCBI exhibited complete color
change and all processed SCBIs
were negative for growth. | Pass |
| Sterility test | Sterility test for medical
devices packaged with
KM Perpak pouch-
LOWTEM | Medical devices packaged in KM
Perpak TM sterilization pouches
after LOWTEM Crystal 120
sterilization cycle have been verified
to maintain the sterility | Pass |

8. Comparison of Subject Device to Predicate Device

Comparison Chart

| Comparison

criteria	Subject Device		Predicate Device
Company	KM Corp.		SIGMA Medical Supplies Corp.
Device Name	Perpak™ Sterilization Tyvek Pouch		Sterilization Pouch/Roll Made with
Tyvek®
Common
name	Sterilization Wrap		Sterilization Wrap
Classification
Regulation	21 CFR 880.6850		21 CFR 880.6850
Product Code	FRG		FRG, JOJ
510(k)
Number	K241123		K180672
Indication for
use	The Perpak™ Sterilization Tyvek Pouch is intended to
provide health care workers with an effective method to
enclose devices intended for sterilization in the
LOWTEM Crystal 120 Sterilizer. The device is
intended to allow sterilization of enclosed devices and
also to maintain sterility of the enclosed devices until
used up to 3 years post sterilization.
Specifications		The Sterilization Pouch/Roll Made with
Tyvek® are intended to provide health
care workers with an effective method to
enclose devices intended for sterilization
in the STERRAD® 100S Sterilizer. The
device is intended to allow sterilization
of enclosed devices and also to maintain
sterility of the enclosed devices until
used up to 3 years post sterilization.
The pouches and rolls are printed with a
chemical indicator bar which is a process
indicator (ISO 11140-1:2005) that
changes from red to blue (or lighter)
	Type	Model name
Dimensions
Max load
(Each material)
Metal (g)
Plastic (g)
		AOB00402
150mm×600mm
170
360
		AOB00164
100mm×350mm
70
10

K241123 510(k) Summary, 3 / 5 page

7

| Sterilization
Pouch Flat
Sterilization
Roll Flat | | AOB00163 | 150mm×700mm | 190 | 370 | when exposed to hydrogen peroxide
vapor during processing in the
STERRAD® 100S Sterilizer. |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|-----|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AOB00162 | 150mm×550mm | 130 | 300 | | |
| | AOB00161 | 150mm×450mm | 80 | 160 | | |
| | AOA00017 | 400mm×200M | 155 | 355 | | |
| | AOA00016 | 300mm×200M | 140 | 340 | | |
| | AOA00015 | 250mm×200M | 100 | 330 | | |
| | AOA00014 | 200mm×200M | 100 | 310 | | |
| | AOA00013 | 150mm×200M | 80 | 160 | | |
| | AOA00012 | 100mm×200M | 70 | 10 | | |
| | AOA00011 | 75mm×200M | 50 | 10 | | |
| Material
Composition | Tyvek®, Ethylene Polymer, Polyethene(PE),
Polyethylene Terephthalate(PET), Bisphenol A-
Epichlorohydrin Resin, Polyester polyol,
Toluene diisocyanate, Methanol | | | | | Tyvek®, PET, PE, Water, CH3COOH,
Alcohol, n-Heptane adhesive, Hydrogen
peroxide vapor Process Indicator Print
Ink |
| Sterilization
Cycles | The Crystal 120 sterilizer's Standard cycle
The recommended Hydrogen Peroxide Sterilization
Cycle parameters are exposure time : 16 minutes
(Hydrogen Peroxide 59%, 2.5g is injected for each of
the 4 sterilization injections), exposure Temperature : 55 ± 5°C, Total cycle time : 53 minutes | | | | | STERRAD® 100S Cycle
The recommended Gas Plasma
Sterilization Cycle parameters are
exposure time: 6 minutes (Injection
volume: 2880µL), exposure Temperature:
50°C, Plasma Stage - Delivered power:
400 Watt. |
| Configuration/
Dimension | Various Size
• Sterilization pouch, Flat
• Sterilization roll, Flat | | | | | Various Size
• Self-sealing sterilization pouches
• Sterilization pouches, Flat
• Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted |
| | Tests conducted on unaged and aged (3 years accelerated aging) devices, before and after sterilization. | | | | | Tests conducted on unaged and aged (3 years accelerated aging) devices, before and after sterilization. |
| Microbial
Barrier
Properties
(Packaging
Integrity) | Thickness Variations | ASTM F 2251 | | | | Thickness Variations |
| | | | | | | ASTM F 2251 |
| | | | | | | Pass |
| | Tensile strength of plastic film | *ASTM D822 | | | | Tensile strength of plastic film |
| | | | | | | *ASTM D822 |
| | | | | | | Pass |
| | Tensile strength of Tyvek® | *ASTM D5035 | | | | Tensile strength of Tyvek® |
| | | | | | | *ASTM D5035 |
| | | | | | Pass | |
| Tear Resistance | *ASTM D1922 | | | | Tear Resistance | |
| | | | | | *ASTM D1922 | |
| | | | | | Pass | |
| Burst Strength | ASTM F1140 | | | | Burst Strength | |
| | | | | | ASTM F1140 | |
| | | | | | Pass | |
| Seal Peel Test | ASTM F88/F88M; ISO 11607-1 | | | | Seal Peel Test | |
| | | | | | ASTM F88/F88M; ISO 11607-1 | |
| | | | | | Pass | |
| Dye penetration Test
(Seal Integrity Test) | ASTM F1929; ISO 11607-1 | | | | Dye penetration Test
(Seal Integrity Test) | |
| | | | | | ASTM F1929; ISO 11607-1 | |
| | | | | | Pass | |
| Microbial Barrier Test | *ASTM F1608 | | | | Microbial Barrier Test | |
| | | | | | *DIN 58953-6 | |
| | | | | | Pass | |
| | *The test items were performed on materials of the
products; therefore, there is no specification
requirements. | | | | *The test items were performed on
materials of the products; therefore, there
is no specification requirements. | |
| Sterilant
Penetration | • Half-Cycle Efficacy
: Showed a 6 log reduction of
Geobacillus
stearothermophilus | | | | | • Half-Cycle Efficacy
: Showed a 6 log reduction of
Geobacillus
stearothermophilus
• Chemical Indicator (CI) Functionality
and Endpoint
: The sterilant penetrated through the
pouch configuration and affected the
CI color change to the endpoint color |

8

Technological Comparison Discussion

The subject device is the same as the predicate device in the intended use, design, and technological characteristics. The difference is that the subject device does not include chemical indicator as the sterilizer which is used with the subject device uses a 510k cleared chemical indicator. Another difference is that the material compositions and we performed various performance tests to support the subject device performance.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K241123, the Perpak™ Sterilization Tyvek Pouch, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K180672.