Who is the manufacturer of Steiking Packaging for Medical Devices?

Wipak OY filed the 510(k) submission for Steiking Packaging for Medical Devices (K210810).

What is the FDA product code for Steiking Packaging for Medical Devices?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Steiking Packaging for Medical Devices?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Steiking Packaging for Medical Devices?

Wipak Steriking Sterilization Pouches & Rolls (K953776).

Who can help prepare an FDA 510(k) submission like Steiking Packaging for Medical Devices?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Steiking Packaging for Medical Devices

K210810 · Wipak OY · FRG · Jan 23, 2022 · General Hospital

Device Facts

Record ID	K210810
Device Name	Steiking Packaging for Medical Devices
Applicant	Wipak OY
Product Code	FRG · General Hospital
Decision Date	Jan 23, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF). Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm)

Device Story

Steriking Packaging for Medical Devices; peel pouch enclosure for medical devices during steam sterilization. Device inserted into pouch; open end heat-sealed (165°C–200°C). Sterilant penetrates through medical-grade paper backing; destroys microorganisms on device surface. Used in clinical settings; operated by healthcare staff. Maintains sterility for 12 months post-sterilization. Protects device integrity; ensures sterile state until point of use.

Clinical Evidence

Bench testing only. Evaluated puncture resistance (ISO 14477), seal integrity (ASTM F1929), sterilant penetration/drying (AAMI TIR 12), microbial barrier (ISO 11607-1), material compatibility (DIN 58953-6), biocompatibility (ISO 10993-5), and shelf life (ASTM F1980). All tests passed, confirming sterility maintenance and package integrity.

Technological Characteristics

Pouch construction: 100g/m2 bleached wood pulp paper backing; transparent front (oriented polyester 12μm, coextruded polypropylene 40μm). Triple heat-sealed. Dimensions: 200mm x 800mm, 250mm x 900mm. Steam sterilization compatible. No software or electronics.

Indications for Use

Indicated for use as an enclosure for medical devices during steam sterilization to maintain sterility until use, for devices with a combined metal and plastic weight of 2.6 lbs or less.

Regulatory Classification

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.

Predicate Devices

Wipak Steriking Sterilization Pouches & Rolls (K953776)

Related Devices

K221016 — Steriking Packaging for Medical Devices · Wipak OY · May 5, 2022
K112591 — SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS · Safe Secure Packaging Co., Ltd. · Feb 7, 2012
K070428 — MEDICOM SELF-SEALING STERILIZATION POUCH · A.R. Medicom, Inc. · Jul 17, 2007
K973440 — REXAM FRACTURE RESISTANT POUCH · Rexam Medical Packaging, Inc. · Oct 20, 1997
K052665 — GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES · Granton Medical , Ltd. · Feb 27, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 23, 2022 Wipak OY % Steven Singleton Consultant Compliance Systems International LLC. 7 Windham Hill Mendon, New York 14056 Re: K210810 Trade/Device Name: Steiking Packaging for Medical Devices Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 14, 2021 Received: December 23, 2021 Dear Steven 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 {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, For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210810 Device Name Steriking Packaging for Medical Devices #### Indications for Use (Describe) Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF). Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm) | 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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {3}------------------------------------------------ 510k Summary K210810 {4}------------------------------------------------ # 4. 510K Summary (in accordance with 21CFR807.92) | | 510K Summary Elements per 21CFR807.92 | Summary | |----|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | a1 | Submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Wipak Oy Wipaktie 2 Nastola Finland Contact: Hanna Marttila Phone: +358 40 124 0290 Date Prepared: 02/03/21 | | a2 | Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name | Proprietary Name: Steriking Packaging for Medical Devices Common Name: Peel Pouch Classification Name: Sterilization wrap, Peel Pouch | | a3 | Identification of the legally marketed device to which the submitter claims equivalence (predicate device) | K953776, Wipak Steriking Sterilization Pouches & Rolls | | a4 | Description of the device | The Steriking Packaging for Medical Devices consists of a paper backing (Bleached wood pulp, grammage $100 g/m2$ ) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of $55 g/m2$ , 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are $165°C – 200°C (329°F - 392°F)$ Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 900mm). | | a5 | Indications for use | Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135°C for 3 minutes; Drying time of 16 minutes The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage $100 g/m2$ ) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of $55 g/m2$ , 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be heat sealed once a device is inserted. Heat sealing | {5}------------------------------------------------ | | | | parameters to provide a sterile barrier are 165°C-200°C (329°F-392°F). Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. | | | Design | Pouches • plastic film triple heat sealed to paper backing • thumb notches • chevron-type seal at end for opening | Similar | Pouches • plastic film triple heat sealed to paper backing • self-seal flap • thumb notches • chevron-type seal at end for opening | |-----------------------------|---------------------------------------------------------------------------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm, 250mm x 900mm) | | | Principle of Operation | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by heat sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 12 months. | Same | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by heat sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. Chemical process indicator is printed exterior on the pouch (printed on medical grade paper) changes color when exposed to sterilant vapor during processing. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 60 months. | | a6 | technological characteristics compared to predicate (as follows) | | See below as follows | | | Dimensions | 200mm x 800mm, 250mm x 875mm | Different | 130 mm X 300 mm, 90 mm X 250 mm, 75mmX300mm | | b1. | Comparison Element | | Submission Device - Steriking Packaging for Medical Devices | Comparison | Predicate Device - Wipak Steriking Peel Pouch, K953776 | Backing Paper | Bleached wood pulp, grammage: 100g/m2 | Similar | Bleached wood pulp, grammage: 70 g/m2 | | | Intended Use | | To serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed devices until used. | Same | To serve as an enclosure for medical devices during steam or gas sterilization that maintains sterility of the enclosed device until used | Tensile Strength MD- kNm | 12.7 | Similar | 10 | | Tensile Strength CD- kNm | 6.7 | Similar | 5.3 | | | | | | | | Tear Strength MD-mN | 1000 | Similar | 750 | | | | | | | | Tear Strength CD-mN | 1100 | Similar | 800 | | | | | | | | Burst Strength-kPa | 690 | Similar | 550 | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | Porosity - Bendtsen | 425 | Same | 425 | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Seal Strength – N/mm | >6.09N/15mm | Similar | 2,1 N/15 mm (Pouch up to 100mm wide) 2,5 N/15 mm (pouch greater than 100mm wide) | | Transparent Film | Two sheets of laminated plastic with a total grammage of 55 g/m2. One sheet of oriented polyester 12 microns thick. One sheet of coextruded polypropylene 40 microns Thick. | Same | Two sheets of laminated plastic with a total grammage of 55 g/m2. one sheet of oriented polyester 12 microns thick. one sheet of coextruded polypropylene 40 microns thick. | | Sterilization Properties | Steam sterilization conditions are 4 minutes at 132º C or 3 minutes at 135º C | Different | Steam sterilization conditions are 3 minutes at 134º C or 15 minutes at 121º C | | Sterilization Process Indicator | NA | Different | Steam Sterilization Process: blue indicators turn brown after steam sterilization. ISO 11140-1:2005 class 1: | | Sterilant Penetration | Full-cycle steam sterilization process will produce sufficient lethality to achieve a 12- log reduction, thus providing a 10-6 Sterility Assurance Level (SAL). Pouches heat sealable do not impede sterilant penetration to the double pouched contents. | Different | Not listed in 510K Summary | | Material Compatibility | Compatible with Steam Sterilization | Same | Compatible with Steam Sterilization | | Package Integrity Test | Closure integrity maintained before and after steam sterilization | Same | Closure integrity maintained before and after steam sterilization | | Maintenance of Sterility - Shelf life post sterilization | 12 months | Different | Not listed in 510K Summary | | Shelf Life - Pre- sterilization | 5 years | Same | 5 Years | | Drying Time | 20 minutes | Different | Not listed in 510K Summary | | Microbial Barrier Properties | The paper of the sterile barrier system was examined on the packaging outer side for its germ proofness with air permeance after steam sterilization and is evaluated as "sufficiently germ-proof" | Different | Not listed in 510K Summary | | Biocompatibility | Non-Cytotoxic | Different | Not listed in 510K Summary | {8}------------------------------------------------ ## Summary of Non-Clinical Testing: Provided below are a listing of performance testing that was used to evaluate the subject device to demonstrate that the device met the specification and the acceptance criteria of the standards and test methodology found in the table below. | Test Methodology | Purpose | Acceptance Criteria | Results | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | ISO 14477 - Packaging. Flexible packaging material. Determination of puncture resistance. | Punture Resistance | No pass/fail criteria | Acceptable =/> 13.1N | | ASTM F1929-15 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration EN 868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods ISO 5636-3 Paper and board — Determination of air permeance | SHELF LIFE Prior to Sterilizaton | Seal Strength: =/>1.5N/15mm Seal Integrity: No dye leaks Air Permeability: =/>3.4um/Pa Peel Properties: free of of fibers after peeling | Pass | | AAMI TIR 12:2010, Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers | Sterilant Penetration & Drying Time | Biological indicator 6-log reduction in half cycle providing 10-6 SAL Drying time post sterilization moisture content weight gain <3% | Pass | | DIN EN ISO -11607-1:2017-10 Section 5.1.6. a) microbisl barrier DIN 953-6, section 4.8.6. DIN 58953-6, section 3.8 and section 4.8.6. | Microbial Barrier Properties | Transmission of CFUs (Colony Forming Units) fron exterior of pouch to interior of pouch = 0 | Pass | | DIN 58953-6, section 3.8 and section 4.8.6. 1. Tensile strength of film ASTM D882 2. Tensile strength of paper (MD) ISO 1924-3 3. Tensile trength of paper (CD) ISO 1924-3 4. Thickness 5. Tear resistance ISO 1974 6. Tear strength DIN 53363 7. Burst strength ISO 2758 8. Air permeance DIN 5636-5 9. Permeance after sterilization DIN 5636-5 10. Seal strength ASTM F88 11. Peel Characteristics EN 868-5:2009 12. Color fastness EIN DIN 646 13. No delamination or clouding 868-5:2009 14. Pinholes in film EN 868-5:2009 | Material Compatibility | 1. =/>20N/15mm 2. =/>66N/15mm 3. =/>33N/15mm 4. =152 +/- 10% μm 5. >550mN (MD & CD) 6. >10N 7. >230kPa 8. 3.9 – 5.7 µm/PAS 9. Corresponds 10. 1.5N/15mm 11. No irregularities or splitting >10mm 12. evaluation grade = 5 13. No objections 14. No pinholes | Pass | | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to <70% of the medium control then test item is considered to have cytotoxic potential | Pass 88% & 92% viability | | ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Shelf Life (post sterilization) | Dye Pentration: none Seal peel: =/>1.5N/15mm | Pass | | ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Package Integrity | No dye penetration/channeling travelling full width of seal in ~5 seconds | Pass | {9}------------------------------------------------ ## Conclusion The conclusions drawn from the non-clinical performance data demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K953776), Class II 21 CFR 880.6850, ProCode FRG.

Steiking Packaging for Medical Devices

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Steiking Packaging for Medical Devices

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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