(246 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray.
The provided document is a 510(k) premarket notification for a medical device (Instru-Safe® Instrument Protection System) and describes the device's intended use and performance testing related to sterilization. It is not an AI/ML device, and therefore, many of the requested categories for AI/ML studies are not applicable.
Here's a breakdown based on the provided text, while noting the irrelevance of AI-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Performance Data Section) | Reported Device Performance (from "Performance Data" and "Performance" sections) |
|---|---|
| Sterilization compatibility (allowing sterilization of enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle with legally marketed wrap or Aesculap rigid container) | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in a Sterrad 100NX Flex Sterilization Cycle with a legally marketed wrap or Aesculap rigid container. This new sterilization cycle does not affect safety and effectiveness of the Instru-Safe Instrument Protection System. The device's "Performance" section explicitly states "Sterrad 100NX Flex Sterilization Cycle" under "Sterilant Penetration." |
| Material Biocompatibility (cytotoxicity) | MEM Elution Cytotoxicity (ISO 10993-5) test samples met USP and ISO 10993-5 requirements, passed, and are considered non-toxic. |
| Shelf Life (reusability) | Reusable (5-year accelerated shelf life study). "No Change" (from predicate device's shelf life). |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the sterilization validation testing. It mentions "Sterilization validation testing was performed" for compatibility with the Sterrad 100NX Flex Sterilization Cycle. The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the nature of validation for a physical medical device, it would most likely be prospective testing conducted in a laboratory or clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device involves demonstrating the physical property of sterilization compatibility and material biocompatibility, which are typically assessed through standardized laboratory tests, not expert interpretation of diagnostic data.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth used would be based on the validated efficacy of the Sterrad 100NX Flex Sterilization Cycle to sterilize medical devices and the results of ISO 10993-5 cytotoxicity testing. This is objective, measurable data from physical and biological tests, not expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Summit Medical Inc. Ms. Nicole Dove Quality Assurance/Regulatory Affairs Manager 815 Northwest Pkwy, Suite 100 St. Paul, MN 55121
Re: K142768
Trade/Device Name: Instru-Safe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 29, 2015 Received: May 1, 2015
Dear Ms. Dove:
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.
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Page 2 - Ms. Dove
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/ResourcesforYou/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. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142768
Device Name Instru-Safe® Instrument Protection System
Indications for Use (Describe)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Sterrad 100NX Flex Sterilization Cycle
| Summit Cassette Model | Aesculap Container Model |
|---|---|
| IN-0000 | *JM444 |
| IN-6105 | *JM440 |
- Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims.
Lumen claims for Sterrad 100NX Flex Sterilization Cycle
| Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens | Wrap / Rigid Container |
|---|---|---|---|---|
| IN-0000 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| IN-8823 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| IN-7344 | 1 mm | 850 mm | 1 | Wrap |
| IN-6105 | 4 mm | 235 mm | 1 | Wrap and Rigid Container |
The worst case validated load by vent-to-volume calculation is the IN-0000 tray. Note: The IN-0000 tray is for testing purposes only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in large, stylized letters, with three diamond shapes above it. Below the word "SUMMIT" is the word "medical" in smaller letters.
Indications for Use Statement
Table 1 - Device Models
.
| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs) |
|---|---|---|
| IN-1315 | 30 | 3.5 |
| IN-2840 | 36 | 8.75 |
| IN-2842 | 24 | 6.5 |
| IN-2843 | 36 | 8.75 |
| IN-2880 | 56 | 12.1 |
| IN-2900 | 22 | 4.18 |
| IN-3030 | 34 | 9.5 |
| IN-5401-12 | 12 | 3.25 |
| IN-7120 | 45 | 11.25 |
| IN-7130 | 45 | 13.5 |
| IN-7223 | 10 | 9.2 |
| IN-7344 | 1 | 4 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| IN-7940 | 20 | 13.25 |
| IN-8240 | 20 | 13.5 |
| IN-8610 | 2 | 6.65 |
| IN-8612 | 2 | 6.8 |
| IN-8613 | 2 | 6.1 |
| IN-8620 | 3 | 7.2 |
| IN-8621 | 4 | 7.18 |
| IN-8622 | 4 | 7.18 |
| IN-8630 | 3 | 6.5 |
| IN-8632 | 3 | 6.45 |
| IN-8633 | 3 | 6.8 |
| IN-8810 | 20 | 13.5 |
| IN-8820 | 15 | 8.75 |
| IN-8823 | 45 | 14 |
| IN-8830 | 15 | 8.75 |
| IN-8833 | 45 | 14 |
| IN-8840 | 20 | 13.75 |
| IN-8850 | 15 | 8.75 |
| IN-8853 | 45 | 14 |
| IN-8882 | 16 | 12.1 |
| 4 | 5.35 | |
| 6 | 12.1 | |
| 6 | 12.1 | |
| 12 | 12.1 | |
| 9 | 7.5 | |
| 5 | 16.1 | |
| 10 | 10.25 | |
| 7 | 6.5 | |
| 22 | 17 | |
| 15 | 13.25 | |
| 22 | 17 | |
| 7 | 12.5 | |
| 16 | 14.5 | |
| 8 | 12.5 | |
| 10 | 11.6 | |
| 11 | 10 | |
| 1 | 2.7 | |
| 6 | 4.7 | |
| 20 | 9.5 | |
| 17 | 9.5 | |
| 16 | 9.5 | |
| ાર | 9.5 | |
| 2 | 6.5 | |
| 2 | 6.5 | |
| 2 | 6 | |
| 2 | 6 | |
| 6 | 12.1 | |
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
phone: 651.789.3939 | fax: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com
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Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of three diamonds arranged horizontally above the word "SUMMIT" in a stylized font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The diamonds and text are all in a dark color, possibly gray or black.
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com
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Image /page/5/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with three blue diamonds above it. Below the word "SUMMIT" is the word "medical" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a professional look.
510(k) Summary
Following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92
| Submitter: | Summit Medical Inc.815 Northwest Parkway, Suite 100St. Paul, MN 55121Tel: (651) 789-3939 | ||
|---|---|---|---|
| ER Number: | 3008719017 | ||
| Contact Person: | Nicole DoveQA/RA ManagerTel: (651) 789-3921ndove@summitmedicalusa.com | ||
| Date Prepared: | May 26, 2015 | ||
| Subject Device: | Trade Name(s):Instru-Safe® Instrument Protection SystemClassification Name:Sterilization wrap containers, trays, cassettes & other accessory (21 CFR 880.6850Common Name:Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery SystemDevice Class:Class IIDevice Code:KCTPanel:General Hospital | ||
| Predicate Device: | Tradename: Instru-Safe Instrument Protection System510(k) Holder: Summit Medical Inc.510(k) #: K133015 | ||
| Device Description: | Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays usedto enclose and hold surgical instruments and accessories in an organized manner duringthe sterilization process and subsequent storage and transportation. The cassettes / traysby themselves do not maintain sterility.The cassettes / trays are different sizes of the same basic configuration: a rectangularbase with latchable cover. The cassettes / trays have perforations to allow sterilantpenetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, |
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979
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Image /page/6/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds arranged horizontally. The logo is simple and modern, and the blue color gives it a professional look.
| organize and protect the surgical instruments within the cassette / tray. | |||||
|---|---|---|---|---|---|
| Intended Use: | Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1. | ||||
| Sterrad 100NX Flex Sterilization Cycle | |||||
| Summit Cassette Model | Aesculap Container Model | ||||
| IN-0000 | *JM444 | ||||
| IN-6105 | *JM440 | ||||
| *Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | |||||
| Lumen claims for Sterrad 100NX Flex Sterilization Cycle | |||||
| SummitCassette Model | MinimumInside Diameter | MaximumLength | Numberof Lumens | Wrap / Rigid Container | |
| IN-0000 | 1 mm | 850 mm | 1 | Wrap and Rigid Container | |
| IN-8823 | 1 mm | 850 mm | 1 | Wrap and Rigid Container | |
| IN-7344 | 1 mm | 850 mm | 1 | Wrap | |
| IN-6105 | 4 mm | 235 mm | 1 | Wrap and Rigid Container | |
| The worst case validated load by vent-to-volume calculation is the IN-0000 tray.Note: The IN-0000 tray is for testing purposes only. | |||||
| The intended use of the subject device includes the Sterrad 100NX Flex Sterilization Cycle. Performance testing has been performed for the Sterrad 100NX Flex Sterilization Cycle. This new sterilization cycle does not affect safety and effectiveness of the Instru-Safe Instrument Protection System. | |||||
| Comparison ofCharacteristicsto PredicateDevice: | Based on a comparison of the design, technology, materials, manufacturing, performance, specifications and methods of use, the Instru-Safe Instrument Protection System is equivalent to the identified 510(k) cleared predicate device. | ||||
| Element | New Device | Predicate (K133015) |
Page 2 of 7
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Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo features the word "SUMMIT" in a stylized font, with the letters connected at the top. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. Above the word "SUMMIT" are three dark blue diamonds arranged horizontally.
| Intended Use | Instru-Safe Instrument Protection System cassettes used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.Sterilization methods and configurations• Sterrad 100NX Flex Sterilization CycleSummit Cassette Model Aesculap Container Model IN-0000 *JM444 IN-6105 *JM440 *Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe System cassettes are not intended on their own to maintain sterility.Sterilization methods and configurations• Autoclave Sterilization Parameter:Cycle: Pre-vacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutesSummit Cassette Model Aesculap Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742 *Validated by Summit Medical for use in steam prevacuum sterilizers ONLY operating at 270°F (132°C) for 4 minutes exposure time. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Material Composition | No changes from predicate device | The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000 | ||||||||||||||
| Physical Properties | Instru-Safe Instrument Protection System cassettes include- perforated base- perforated cover | Instru-Safe Instrument Protection System cassettes include- perforated base- perforated cover |
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
phone: 651.789.3939 | fax: 651.789.3979
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Image /page/8/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a large, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the blue color gives it a professional look.
| ChemicalProperties | - silicone inserts (hold-it / hold down)- Handles- Latches- Feet- Posts (optional)- Divider (optional)- Shelf (optional)Not Applicable | - silicone inserts (hold-it / hold down)- Handles- Latches- Feet- Posts (optional)- Divider (optional)- Shelf (optional)Not Applicable |
|---|---|---|
| Configurations/Dimensions | Various configurations / dimensions | See table located in predicate devicesubmission K133015 |
| Air permeance | Not Applicable | Not Applicable |
| Percent ofsurfaceperformations | Not Applicable | Not Applicable |
| Performance | New Device | Predicate (K133015) |
| SterilantPenetration | Sterrad 100NX Flex Sterilization Cycle | Pre-Vacuum SteamCycle: Pre-vacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes |
| MicrobialBarrierProperties(PackagingIntegrity) | Not Applicable | Not Applicable |
| MaterialCompatibility | No changes from predicate device | Refer to predicate device K133015 |
| ToxicologicalProperties(Biocompatibility, includingSterilantResidue Limits) | MEM Elution Cytotoxicity (ISO 10993-5)- The test samples meet the USP and ISO10993-5 requirements for this test. Allcontrols were acceptable and the testconsidered valid. The test samplesPASSED and are considered NON-TOXIC under the test conditionsemployed. | Refer to predicate device K133015 |
| Shelf Life | No Change | Reusable (5 year accelerated shelf lifestudy) |
| Drying Time | Not Applicable | Autoclave Sterilization Parameter:Cycle: Pre-VacuumTemperature: 270°F (132°C)Minimum Exposure Time: 4 minutes |
| Minimum Dry Time: 30 minutes | ||
| Aeration Time | Not Applicable | Not Applicable |
| TechnologicalCharacteristics: | The technological characteristics of the subject devices are equivalent to the predicatedevices. The cassettes / trays are made of standard medical grade materials and do notincorporate any new technological characteristics. | |
| PerformanceData: | Sterilization validation testing was performed to demonstrate Instru-Safe InstrumentProtection System compatibility when used in a Sterrad 100NX Flex Sterilization Cyclewith a legally marketed wrap or Aesculap rigid container. | |
| Conclusion: | Based upon intended use, performance data and technical information provided in thispre-market notification, the Instru-Safe® Instrument Protection System described hereinis substantially equivalent to the predicate device [Instru-Safe® Instrument ProtectionSystem (K133015)]. |
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979
Page 4 of 7
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Image /page/9/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
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Image /page/10/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds arranged in a row. The logo is simple and modern, and the blue color gives it a professional look.
| Table 1 - Device Models | |||||||
|---|---|---|---|---|---|---|---|
| ------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs) |
|---|---|---|
| IN-1315 | 30 | 3.5 |
| IN-2840 | 36 | 8.75 |
| IN-2842 | 24 | 6.5 |
| IN-2843 | 36 | 8.75 |
| IN-2880 | 56 | 12.1 |
| IN-2900 | 22 | 4.18 |
| IN-3030 | 34 | 9.5 |
| IN-5401-12 | 12 | 3.25 |
| IN-7120 | 45 | 11.25 |
| IN-7130 | 45 | 13.5 |
| IN-7223 | 10 | 9.2 |
| IN-7344 | 1 | 4 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| IN-7940 | 20 | 13.25 |
| IN-8240 | 20 | 13.5 |
| IN-8610 | 2 | 6.65 |
| IN-8612 | 2 | 6.8 |
| IN-8613 | 2 | 6.1 |
| IN-8620 | 3 | 7.2 |
| IN-8621 | 4 | 7.18 |
| IN-8622 | 4 | 7.18 |
| IN-8630 | 3 | 6.5 |
| IN-8632 | 3 | 6.45 |
| IN-8633 | 3 | 6.8 |
| IN-8810 | 20 | 13.5 |
| IN-8820 | 15 | 8.75 |
| IN-8823 | 45 | 14 |
| IN-8830 | 15 | 8.75 |
| IN-8833 | 45 | 14 |
| IN-8840 | 20 | 13.75 |
| IN-8850 | 15 | 8.75 |
| IN-8853 | 45 | 14 |
| IN-8882 | 16 | 12.1 |
| IN-8884 | 4 | 5.35 |
| IN-8886 | 6 | 12.1 |
| IN-8889 | 6 | 12.1 |
| IN-8892-01 | 12 | 12.1 |
| IN-8893 | 9 | 7.5 |
| IN-8894 | 5 | 16.1 |
| IN-8898 | 10 | 10.25 |
| IN-8899 | 7 | 6.5 |
| IN-8902 | 22 | 17 |
| IN-8903 | 15 | 13.25 |
| IN-8904 | 22 | 17 |
| IN-8907 | 7 | 12.5 |
| IN-8937 | 16 | 14.5 |
| IN-8938 | 8 | 12.5 |
| IN-8939 | 10 | 11.6 |
| IN-8942 | 11 | 10 |
| IN-8943 | 1 | 2.7 |
| IN-8944 | 6 | 4.7 |
| IN-8980-01 | 20 | 9.5 |
| IN-8982-01 | 17 | 9.5 |
| IN-8983-01 | 16 | 9.5 |
| IN-8984-01 | 15 | 9.5 |
| IN-8986-S | 2 | 6.5 |
| IN-8987-S | 2 | 6.5 |
| IN-8988-S | 2 | 6 |
| IN-8989-S | 2 | 6 |
| IN-9999-160 | 6 | 12.1 |
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com
Page 6 of 7
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Image /page/11/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a bold, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com
Page 7 of 7
§ 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).