(269 days)
Not Found
No
The device description and performance studies focus on the physical design and sterilization efficacy of a container system, with no mention of AI or ML technologies.
No
This device is a reusable container system for sterilizing medical instruments, not a device used to provide therapy directly to patients.
No
The device is a container system used for steam sterilization of medical instruments, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as a lid, base, basket, gasket, latches, and valves, indicating it is a hardware device.
Based on the provided information, the FlashPak® device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the FlashPak® is a reusable container system for sterilizing medical devices using steam sterilization. Its purpose is to enable sterilization and prevent recontamination of instruments used in patient care.
- Device Description: The description details a physical container with a lid, base, basket, seals, and valves designed to facilitate steam sterilization.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FlashPak® does not interact with human specimens or provide diagnostic information.
- Performance Studies: The performance studies focus on sterilization efficacy (achieving a certain sterility assurance level), which is relevant to the reprocessing of medical devices, not to in vitro diagnostic testing.
Therefore, the FlashPak® is a medical device used in the sterilization process of other medical devices, not an IVD.
N/A
Intended Use / Indications for Use
FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items and items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
FlashPak® Model/Maximum Instrument Load Weight Recommendation:
9020 w/9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg)
9030 w/9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55Kg)
9040 w/9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg)
9050 w/9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.
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
hospitals and healthcare facilities
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 sterilization parameters tested were taken from ANSI/AAMI ST79 for IUSS. Testing consisted of sterilization efficacy studies for the additional sterilizations. The over kill test method described in ISO 17665-1 was applied. A worst case loading configuration was utilized; i.e. maximum recommended weight of routine metal instruments.
Biologic indicators (Bl) with resistant Geobacillus Stearothermophilus were placed throughout the container among the devices and four devices were directly inoculated. Half cycles were run three times for each sterilization mode, gravity displacement and dynamic-air removal. Following sterilization the Bls were aseptically removed and processed to culture media then incubated to observe for any microbial growth. In every run there was no observed microbial growth indicating an SAL of 10* was achieved. Positive and negative controls were concurrently processed and passed as well.
Conclusion: Performance testing data demonstrates the the FlashPak® Sterilization Container is substantially equivalent to the predicate device.
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.
FlashPak® Sterilization Container System, K113776
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Symmetry Surgical, Inc. Mr. Christopher Smith, RAC Senior Director of QA/RA 3034 Owen Drive Antioch, TN 37013
Re: K141826
Trade/Device Name: FlashPak® Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 18, 2015 Received: February 23, 2015
Dear Mr. Smith:
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. 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.
1
Page 2 - Mr. Smith
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141826
Device Name FlashPak® Sterilization Container System
Indications for Use (Describe)
FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The containle with pre-vacum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak® is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
FlashPak® Model/Maximum Instrument Load Weight Recommendation:
9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg)
9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg)
9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg)
9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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រៀត
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Image /page/3/Picture/0 description: The image contains the logo for Symmetry Surgical. The logo consists of a stylized letter "S" made up of red and gray shapes, followed by the text "symmetry surgical" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company name.
510K Summary of Safety and Effectiveness (Per 21 CFR 807.92)
General Company Information
| Company Name: | Symmetry Surgical |
|---|---|
| Company Address: | 3034 Owen Drive |
| Antioch, TN 37013 | |
| Company Telephone: | 615-964-5392 |
| Contact: | Christopher M. Smith |
| Sr. Director of QA/RA | |
| Contact Address & Telephone: | 3034 Owen Drive |
| Antioch, TN 37013 | |
| 615-964-5392 | |
| Date: | April 2, 2015 |
| Device Trade Name: | FlashPak® Sterilization Container System |
| Common Name: | Wrap, Sterilization |
| Classification, Regulation # and | |
| Product Code: | Class II - 880.6850 - FRG |
| Predicate Device: | FlashPak® Sterilization Container System, K113776 |
Image /page/3/Picture/5 description: The image is a solid red color. The shape is a rectangle that is slightly distorted. The right side of the rectangle is curved inward.
3034 Owen Drive, Antioch, TN 37013 Office 800.251.3000 615,964,5567 Fax = symmetrysurgical.com
Image /page/3/Picture/7 description: The image is a close-up shot of a dark, textured surface. The surface appears to be made of a rough material, possibly stone or concrete. The lighting is dim, which accentuates the texture and creates shadows. The left side of the image has a curved edge, while the rest of the image is more rectangular.
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Device Description:
The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.
Intended Use:
The intended use of the predicate device was changed to add additional steam sterilizations. The 3 minute gravity displacement cycle at 132 ºC and 3 minute dynamic-air removal cycle at 132 ºC were validated and added to the following intended use statement.
"FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
FlashPak® Model/Maximum Instrument Load Weight Recommendation:
| 9020 w/9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg) |
|---|
| 9030 w/9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55Kg) |
| 9040 w/9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg) |
| 9050 w/9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg) |
Substantial Equivalence Discussion
The predicate device is the FlashPak Sterilization Container System cleared under 510(k) #K113776. The predicate device and the subject device are physically identical. They are the same device. The differences between the predicate and the subject device involve the steam sterilization parameters recommended in the instructions for use (IFU) and intended use statement. The subject device has additional immediate use steam sterilization parameters recommended for its use that were taken from ANSI/AAMI ST79 and were validated for efficacy.
Image /page/4/Picture/10 description: The image is a solid red color. The shape is rectangular, but the right side is slightly curved. The red color is uniform throughout the image.
34 Owen Drive, Antioch, TN 37013 615 964 5567 symmetry surgical.com
Image /page/4/Picture/12 description: The image is a close-up shot of a dark, textured surface. The surface appears to be slightly curved on the left side, creating a rounded edge. The texture is grainy and uneven, with subtle variations in shading that suggest depth and dimension. The overall impression is one of a solid, unyielding material with a rough, natural finish.
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A comparison of the similarities and differences between the predicate device and the subject device is provided in the table below. The table follows the elements of interest defined in the guidance for Industry and FDA—Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities of March 7, 2002.
| ELEMENT | PREDICATE | SUBJECT DEVICE |
|---|---|---|
| Intended Use | FlashPak® is a reusable rigid | |
| container system to be used during | ||
| flash sterilization by hospitals and | ||
| healthcare facilities. It is intended | ||
| to enable flash sterilization of the | ||
| enclosed devices and prevent | ||
| recontamination during immediate | ||
| transport to the point of use. The | ||
| container is compatible with | ||
| gravity-displacement flash | ||
| sterilization using a 10 minute cycle | ||
| at 132° C and with pre-vacuum | ||
| flash sterilization using a 4 minute | ||
| cycle at 132° C. FlashPak is | ||
| recommended for surface | ||
| sterilization of stainless steel | ||
| instruments and for lumens with | ||
| the following limits: gravity- | ||
| displacement (5.5mm inner | ||
| diameter or larger and up to | ||
| 184mm in length), pre-vacuum | ||
| (1mm inner diameter or larger and | ||
| up to 203mm in length). | FlashPak® is a reusable rigid | |
| container system to be used during | ||
| immediate use steam sterilization | ||
| (IUSS or flash) by hospitals and | ||
| healthcare facilities. It is intended | ||
| to enable sterilization of the | ||
| enclosed devices and prevent | ||
| recontamination during immediate | ||
| transport to the point of use. The | ||
| container is compatible with | ||
| gravity-displacement steam | ||
| sterilization using a 10 minute cycle | ||
| at 132° C for porous items and | ||
| items with lumens or a 3 minute | ||
| cycle at 132° C for nonporous items | ||
| like routine metal instruments. The | ||
| container is also compatible with | ||
| pre-vacuum steam sterilization | ||
| using a 4 minute cycle at 132° C for | ||
| porous items and items with | ||
| lumens or a 3 minute cycle for | ||
| nonporous items like routine metal | ||
| instruments. FlashPak is | ||
| recommended for sterilization of | ||
| lumens with the following limits: | ||
| gravity-displacement (5.5mm inner | ||
| diameter or larger and up to | ||
| 184mm in length), pre-vacuum | ||
| (1mm inner diameter or larger and | ||
| up to 203mm in length). | ||
| Container: | ||
| Radel R5000 series base and lid; | ||
| SS (304) Instrument Basket; | ||
| ELEMENT | PREDICATE | SUBJECT DEVICE |
| Material Composition | SS (304) Latches; | Same as predicate |
| Clear Medical Grade Silicone Gasket | ||
| and Valve Seal; | ||
| SS (300) Hardware; | ||
| Sintered SS Filter Disk; | ||
| Silicone Lid Vent Button | ||
| Valve: | ||
| SS (304) Bellows; | ||
| SS (316) Bracket | ||
| Physical Properties | Materials used in the FlashPak are | |
| commonly used in many other | ||
| legally marketed sterilization trays | ||
| and cases. Physical properties of | ||
| the system materials and | ||
| construction have a demonstrated | ||
| long history of safe and effective | ||
| use for this application. | Same as predicate | |
| Chemical Properties | Materials used in the FlashPak are | |
| commonly used in many other | ||
| legally marketed sterilization trays | ||
| and cases. Chemical properties of | ||
| the system materials and | ||
| construction have a demonstrated | ||
| long history of safe and effective | ||
| use for this application. | Same as predicate | |
| Configurations/Dimensions | Container Sizes: | |
| (11" x 11" x 7") #9020 | ||
| (20" x 11" x 8"), #9030 | ||
| (24" x 11" x 9") #9040 | ||
| (24" x 13" x 9") #9050 | Same as predicate | |
| ELEMENT | PREDICATE | SUBJECT DEVICE |
| Air Permeance | N/A | |
| Container operates with valves, no | ||
| filters, wraps or perforations | N/A | |
| Percent of Surface | ||
| Perforations | N/A | |
| Container is not perforated | N/A | |
| PERFORMANCE | PREDICATE | NEW DEVICE |
| Sterilant Penetration | Sterilization Efficacy | |
| Gravity-displacement Cycle: | ||
| 10 minutes at 132°C(270°F) for porous and cannulated devicesDynamic-air-removal Cycle4 minutes at 132°C(270°F) for porous and cannulated devices | Same as predicate with the added indications for: | |
| Gravity-displacement Cycle:3 minutes at 132°C(270°F) for nonporous and routine metal devicesDynamic-air-removal Cycle3 minutes at 132°C(270°F) for nonporous and routine metal devices | ||
| Sterilant Penetration | ||
| Three thermal mapping studies for each of the two sterilization modes demonstrating a precise match (within seconds) between the chamber and container temperature profiles. | ||
| Microbial Barrier Properties | ||
| (Packaging Integrity) | The container completely encapsulates the items sterilized inside with the use of a silicone lid gasket, a silicone lid vent, sintered SS microfilter and silicone valve seals to provide an effective microbial barrier during transport to the point of use immediately | Same as predicate |
| ELEMENT | PREDICATE | SUBJECT DEVICE |
| after sterilization. | ||
| Container passed a microbial aerosol challenge test by preventing microbial ingress during a one hour exposure to aerosolized microbes in a closed chamber. | ||
| Material Compatibility | Materials used in the FlashPak are commonly used in many other legally marketed sterilization trays and cases. The system materials and construction have a demonstrated long history of safe and effective use for this application. | Same as predicate |
| Toxicological Properties | ||
| (Biocompatibility, including | ||
| Sterilant Residue Limits) | Materials used are either medical grade polymers or stainless steel. Instruments placed in the container only come in contact with the Stainless Steel wire basket. Cytotoxicity and Intracutaneous Reactivity studies were completed on the final configuration. | Same as predicate |
| N/A | ||
| Shelf Life | FlashPak is intended for immediate use steam sterilization | Same as predicate |
| N/A | ||
| Drying Time | FlashPak is intended for immediate use steam sterilization | Same as predicate |
| Aeration Time & EtO | ||
| Residuals | N/A | |
| FlashPak is only recommended for steam sterilization | N/A |
Image /page/5/Picture/4 description: The image is a close-up shot of a red parallelogram. The parallelogram is a solid color, with no visible texture or pattern. The shape is slightly distorted, with the right side curving inward. The lighting is even, and there are no shadows or highlights.
3034 Owen Drive, Antioch, TN 37013 Office 800.251.3000 615 964.5567 Fax symmetrysurgical.com
Image /page/5/Picture/6 description: The image is a close-up shot of a dark, textured surface. The surface appears to be slightly curved on the left side, and the texture is rough and uneven. The lighting is dim, which makes it difficult to discern the details of the surface. The overall impression is one of a weathered, aged material.
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Image /page/6/Picture/0 description: The image shows the logo for Symmetry Surgical. The logo consists of a stylized "S" made up of gray and red shapes, followed by the words "symmetry surgical" in gray sans-serif font. The word "surgical" is slightly smaller than the word "symmetry".
Image /page/6/Picture/5 description: The image is a close-up shot of a solid red color on the left side, gradually transitioning to white on the right. The red portion occupies a significant part of the image, while the white area appears as a curved shape on the right edge. The transition between the two colors is smooth, creating a visually simple yet striking composition.
3034 Owen Drive, Antioch, TN 37013 Office 800.251.3000
Fax symmetrysurgical.com
Image /page/6/Picture/4 description: The image is a close-up shot of a dark, solid surface. The surface appears to be slightly textured, with subtle variations in tone and shade. The lighting is somewhat diffused, creating a soft, even illumination across the surface. The overall impression is one of simplicity and understated texture.
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Image /page/7/Picture/0 description: The image shows the logo for Symmetry Surgical. The logo consists of a stylized "S" symbol on the left, followed by the text "symmetry surgical" in a sans-serif font. The "S" symbol is made up of red and gray shapes.
Image /page/7/Picture/2 description: The image is a solid red color. The shape is a rectangle that is slightly curved on the right side. The red color is consistent throughout the image.
3034 Owen Drive, Antioch, TN 37013 Qffice 800 251.3000
Fax symmetrysurgical.com
Image /page/7/Picture/4 description: The image is a close-up shot of a dark, textured surface. The surface appears to be slightly curved on the left side, and the texture is somewhat rough and uneven. The overall tone of the image is dark and muted, with subtle variations in shading across the surface.
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Image /page/8/Picture/0 description: The image contains the logo for Symmetry Surgical. The logo consists of two stylized letter 'S' shapes, one in red and one in gray, positioned next to each other. To the right of the logo is the text "symmetry surgical" in a gray, sans-serif font.
Image /page/8/Picture/2 description: The image is a solid red rectangle. The rectangle is slightly distorted, with the top and bottom edges not perfectly parallel. The color is a bright, saturated red, and there are no other colors or objects in the image.
3034 Owen Drive, Antioch, TN 37013 Office 800.251.3000
Fax symmetrysurgical.com
Image /page/8/Picture/4 description: The image is a close-up shot of a dark gray or black surface. The surface appears to be textured or slightly rough, with subtle variations in tone and shading. The lighting is soft and diffused, creating a smooth and even illumination across the surface. The overall impression is one of simplicity and understated elegance.
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Technological Characteristics:
The technological characteristics of the subject device are identical to the predicate since there have been no physical changes made to the device. The materials, manufacturing and fundamental scientific technology are the same.
Performance Data:
The sterilization parameters tested were taken from ANSI/AAMI ST79 for IUSS. Testing consisted of sterilization efficacy studies for the additional sterilizations. The over kill test method described in ISO 17665-1 was applied. A worst case loading configuration was utilized; i.e. maximum recommended weight of routine metal instruments.
| FlashPak Model | Maximum Instrument Load Weight Recommendation | |
|---|---|---|
| Gravity | Pre-Vacuum | |
| 9020 | ||
| w/ 9020-08 Basket | 3 pounds (1.36 Kg) | 3 pounds (1.36 Kg) |
| 9030 | ||
| w/ 9030-08 Basket | 10 pounds (4.55 Kg) | 10 pounds (4.55 Kg) |
| 9040 | ||
| w/ 9040-08 Basket | 14 pounds (6.35 Kg) | 14 pounds (6.35 Kg) |
| 9050 | ||
| w/ 9050-08 Basket | 16 pounds (7.27 Kg) | 16 pounds (7.27 Kg) |
Biologic indicators (Bl) with resistant Geobacillus Stearothermophilus were placed throughout the container among the devices and four devices were directly inoculated. Half cycles were run three times for each sterilization mode, gravity displacement and dynamic-air removal. Following sterilization the Bls were aseptically removed and processed to culture media then incubated to observe for any microbial growth. In every run there was no observed microbial growth indicating an SAL of 10* was achieved. Positive and negative controls were concurrently processed and passed as well.
Conclusion: Performance testing data demonstrates the the FlashPak® Sterilization Container is substantially equivalent to the predicate device.
Image /page/9/Picture/9 description: The image is a solid red color. The shape is a quadrilateral, but the right side is curved. The red color is consistent throughout the image.
034 Owen Drive, Antioch, TN 37013 800 251 3000 615 964 5567 symmetrysurgical.com
Image /page/9/Picture/11 description: The image is a close-up shot of a dark, textured surface. The surface appears to be slightly curved on the left side, creating a concave shape. The texture is rough and uneven, with variations in color and tone throughout the surface. The overall impression is that of a solid, unyielding material with a natural or weathered appearance.