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 Amsco V-PRO Low Temperature Sterilization Cycles. 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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Instru-Safe® Instrument Protection System), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. The document primarily details the device's intended use and compares its characteristics and performance to a previously cleared predicate device.

Therefore, many of the requested elements for describing an acceptance criteria study, such as sample size for test sets, ground truth establishment for test and training sets, the number and qualifications of experts, adjudication methods, or MRMC studies, are not explicitly mentioned or applicable in this type of regulatory submission.

However, based on the information provided, here's an attempt to address the request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the intended use and the predicate device's performance. The "Performance Data" section in the summary directly addresses this.

Acceptance Criterion (Implied)	Reported Device Performance
Sterilant Penetration in Amsco V-PRO Low Temperature Sterilization Systems (Standard, Lumen, Non Lumen Cycles)	Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in an Amsco V-PRO Low Temperature Sterilization Systems with a legally marketed wrap or Aesculap rigid container.
Material Compatibility	No changes from predicate device (K133015).
Toxicological Properties (Biocompatibility/Cytotoxicity)	MEM Elution Cytotoxicity (ISO 10993-5): Test samples met USP and ISO 10993-5 requirements; considered non-cytotoxic under test conditions.
Shelf Life	No Change (Reusable, 5-year accelerated shelf life study for predicate device).

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of an AI/algorithm study. For the sterilization validation, the specific number of units tested (cassettes/trays, instruments, sterilization cycles) is not provided. The data provenance would be from internal testing conducted by Summit Medical Inc. as part of their regulatory submission. The study is prospective in nature for a new device attempting to be cleared for the specified sterilization cycles.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not describe the establishment of ground truth by experts for a test set in the context of an AI/algorithm. The "ground truth" for sterilization effectiveness would be determined by standard microbiological and physical indicator tests, which do not typically involve human expert interpretation in the same way as, for example, image analysis.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication for a test set as this is not an AI/algorithm performance study.

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-assisted device, and no MRMC study was performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical instrument protection system, not a software algorithm.

7. The type of ground truth used

For the sterilization validation, the ground truth would be established through sterilization effectiveness testing using biological and chemical indicators, which are standard methods to confirm the complete inactivation of microorganisms. For the biocompatibility claim, the ground truth was established by laboratory testing against ISO 10993-5 requirements.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 22, 2015

Summit Medical Inc. Ms. Nicole Dove Quality Assurance/Regulatory Affairs Manager 815 Northwest Pkwy, Suite 100 St. Paul, MN 55121

Re: K150540

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: May 20, 2015 Received: May 22, 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.

{1}------------------------------------------------

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/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. 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) K150540

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. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Amsco V-PRO Low Temperature Sterilization Cycles. The 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.

			Amsco V-PRO Low Temperature Sterilization Cycles:
--	--	--	---------------------------------------------------	--	--

Sterilizer	StandardCycle	LumenCycle	Non LumenCycle
V-PRO 1	X	N/A	N/A
V-PRO 1 Plus	N/A	X	X
V-PRO maX	N/A	X	X

Summit Cassette Model	Aesculap Container Model
IN-8823	*JM444
IN-6105	*JM742

Validated by Summit Medical for use in Amso V-PRO Low Temperature Sterilization systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.

Lumen size of instrumentation validated includes:
Summit Cassette Model	Minimum Inside Diameter	Maximum Length	Number of Lumens
IN-8823	3 mm	400 mm	2
IN-6105	3 mm	200 mm	1
IN-2681	1 mm	64 mm	1

The worst case validated load by vent-to-volume calculation is the IN-2681 tray.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

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."

{4}------------------------------------------------

Image /page/4/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, sans-serif font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo has a clean and modern design.

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-2006	8	2
IN-2681	13	0.64
IN-2682	13	0.89
IN-2683	13	1.39
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-2950	12	4.1
IN-3030	34	9.5
IN-4000	20	3.2
IN-4003	30	3.25
IN-4010	10	1.98
IN-5009	8	5
IN-5401	6	2
IN-5401-02	2	1
IN-5401-03	2	1
IN-5401-08	8	3.2
IN-5401-12	12	3.25
IN-6103	2	2.15
IN-6105	2	2.15
IN-6110	3	2.15
IN-6203	2	2.75
IN-6205	2	2.75
IN-6210	2	2.75
IN-6240	2	2.75
IN-6303	2	3.28
IN-6305	2	3.28
IN-6310	2	3.28
IN-6403	2	3.28
IN-6405	2	3.28
IN-6410	2	3.28
IN-6500	30	12.5
IN-7010	2	2
IN-7012	1	1.07
IN-7020	30	8.5
IN-7030	30	10
IN-7032	2	1.1
IN-7073	10	5
IN-7120	45	11.25
IN-7123	45	12
IN-7130	45	13.5
IN-7140	45	14.5
IN-7150	8	1.9
IN-7153	6	1.7
IN-7220	45	14.5
IN-7223	10	9.2
IN-7230	45	14.5
IN-7234	45	14.5
IN-7240	45	14.5
IN-7250	45	14.5
IN-7252	25	8
IN-7260	45	14.5
IN-7273	10	6
IN-7274	30	8
IN-7322	45	14.5
IN-7323	45	14.5
IN-7343	45	14.5
IN-7344	1	4
IN-7360	45	14.5
IN-7423	45	14.5
IN-7452	10	8
IN-7453	10	8
IN-7540	45	14.5
IN-7560	45	14.5
IN-7644	45	14.5
IN-7723	15	7.18
IN-7724	15	7.2
IN-7725	10	9.5
IN-7781	45	14.5
IN-7823	45	14.5
IN-7830	45	14.5
IN-7840	45	13.5
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-8615	2	5.8
IN-8616	2	5.8
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-8640	4	5.35
IN-8642	4	5.35
IN-8643	5	5.35
IN-8645	4	5.35
IN-8650	4	5.85
IN-8660	4	5.35
IN-8662	4	5.35
IN-8663	3	5.5
IN-8700	40	14
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-8860	15	8.75
IN-8862	30	10.5
IN-8863	45	14
IN-8880	2	3.28
IN_8882	16	12.1
IN-8883	2	3.28
IN-8884	4	5.35
IN-8885	1	2.25
IN-8886	6	12.1
IN-8889	6	12.1
IN-8891-S	1	2
IN-8891-SI-12-S	1	2
IN-8891-SI-85-S	1	2
IN-8892	12	12.1
IN-8893	9	7.5
IN-8894	5	16.1
IN-8897	8	6
IN-8898	10	10.25
IN-8899	7	6.5
IN-8901	1	2.25
IN-8902-G2	22	17
IN-8903	15	13.25
IN-8904	22	17
IN-8907	7	12.5
IN-8931	1	2.4
IN-8932	9	9.5
IN-8933	3	3.75
IN-8936	6	11.5
IN-8937	16	14.5
IN-8938	8	12.5
IN-8939	10	11.6
IN-8940	5	5.18
IN-8942	11	10
IN-8943	1	2.7
IN-8944	6	4.7
IN-8945	2	5.18
IN-8946	9	6.1
IN-8980	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
IN-9999-162-S	2	5.8
IN-9999-168-S	2	5.8
IN-9999-172-S	2	5.8
IN-9999-178-S	2	5.8

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com

{5}------------------------------------------------

Image /page/5/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.

{6}------------------------------------------------

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 underneath. 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.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a 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.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a 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 use of blue gives it a professional and trustworthy feel.

{9}------------------------------------------------

Image /page/9/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, arranged horizontally. The logo is simple and modern, and the use of blue suggests trust and reliability.

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
ContactPerson:	Nicole DoveQA/RA Manager Tel: (651)789-3921ndove@summitmedicalusa.com
Date Prepared:	June 22, 2015
SubjectDevice:	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 DeliverySystemDevice Class:Class IIDevice Code:KCTPanel:General Hospital
PredicateDevice:	Tradename: Instru-Safe Instrument Protection System510(k) Holder: Summit Medical Inc.510(k) #: K133015
DeviceDescription:	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.

Page 1 of 11

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of three blue diamonds arranged horizontally above the word "SUMMIT" in a stylized font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The overall design is clean and professional, suggesting a healthcare or medical-related organization.

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.
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 Amsco V-PRO Low Temperature Sterilization Cycles. 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.
Amsco V-PRO Low Temperature Sterilization Systems
Sterilizer	Standard Cycle	Lumen Cycle	Non Lumen Cycle
V-PRO 1	X	N/A	N/A
V-PRO 1 Plus	N/A	X	X
V-PRO maX	N/A	X	X
Summit Cassette Model	Aesculap Container Model
IN-8823	*JM444
IN-6105	*JM742
*Validated by Summit Medical for use in Amsco V-PRO Low Temperature Sterilization Systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.
Lumen size of instrumentation validated includes:
Summit Cassette Model	Minimum Inside Diameter	Maximum Length	Number of Lumens
IN-8823	3mm	400mm	2
IN-6105	3mm	200mm	1
IN-2681	1mm	64mm	1
The worst case validated load by vent-to-volume calculation is the IN-2681 tray. The intended use of the subject device includes the Amsco V-PRO Low Temperature Sterilization Systems. Performance testing has been completed for the Amsco V-PRO Low Temperature Sterilization Systems. These new sterilization cycles do not affect safety and effectiveness of the Instru-Safe Instrument Protection System.
Comparison of Characteristics to Predicate Device:	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)

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 2 of 11

{11}------------------------------------------------

Image /page/11/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. The logo is simple and modern, and the use of blue gives it a professional look.

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 Amsco V-PRO Low Temperature Sterilization Cycles. 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.
	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	Sterilization methods and configurations
	Amsco V-PRO Low Temperature Sterilization Systems	• Autoclave Sterilization Parameter:Cycle: Pre-vacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes
Sterilizer	Standard Cycle	Lumen Cycle	Non Lumen Cycle
V-PRO 1	X	N/A	N/A
V-PRO 1 Plus	N/A	X	X
V-PRO MAX	N/A	X	X
Summit Cassette Model	Aesculap Container Model
IN-8823-AE	*JN444
IN-2880	*JK444
IN-6105	*JN742
IN-8823	*JM444
IN-6105	*JM742
*Validated by Summit Medical for use in Amsco V-PRO Low Temperature Sterilization Systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.		*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 container intended load claims.

Page 3 of 11

{12}------------------------------------------------

Lumen size of instrumentation validated includes:
SummitCassetteModel	MinimumInsideDiameter	MaximumLength	Number ofLumens
IN-8823	3mm	400mm	2
IN-6105	3mm	200mm	1
IN-2681	1mm	64mm	1
The worst case validated load by vent-to- volume calculationis the IN-2681 tray.
MaterialComposition	No changes from predicate device		The cassette containscomponents madeof anodized aluminum,stainless steel, blue
PhysicalProperties	Instru-Safe Instrument ProtectionSystem cassettes include- perforated base- perforated cover- silicone inserts (hold-it / hold down)- Handles- Latches- Feet- Posts (optional)- Divider (optional)- Shelf (optional)		Instru-Safe InstrumentProtectionSystem cassettes include- perforated base- perforated cover- siliconeinserts (hold-it / holddown)- Handles- Latches- Feet
ChemicalProperties	Not Applicable		Not Applicable
Configurations/ Dimensions	Various configurations / dimensions		See table located inpredicate device
Air permeance	Not Applicable		Not Applicable

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 4 of 11

{13}------------------------------------------------

Percent ofsurfaceperformations	Not Applicable	Not Applicable
Performance	New Device	Predicate
Sterilant	Amsco V-PRO Low Temperature	Pre-Vacuum Steam
Penetration	Sterilization Systems.	Cycle: Pre-
		vacuum
		Temperature:
		270°F (132°C)
Microbial	Not Applicable	Not Applicable
Barrier
Properties
(Packaging
Integrity)
Material	No changes from predicate device	Refer to predicate device
Compatibility		K133015
Toxicological	MEM Elution Cytotoxicity (ISO	Refer to predicate device
Properties	10993-5)	K133015
(Biocompatibil	The test samples meet the USP and-
ity, including	ISO 10993-5 requirements for this

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a large, bold, 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 and trustworthy look.

SterilantResidueLimits)	test. All controls were acceptableand the test considered valid. Thetest samples PASSED and areconsidered NON-CYTOTOXICunder the test conditions employed.
Shelf Life	No Change	Reusable (5 year accelerated shelf lifestudy)
Drying Time	Not Applicable	Autoclave Sterilization Parameter:Cycle: Pre-Vacuum Temperature:270°F (132°C) Minimum ExposureTime: 4 minutes Minimum Dry Time:30 minutes
Aeration Time	Not Applicable	Not Applicable
TechnologicalCharacteristics:	The technological characteristics of the subject devices are equivalent to thepredicate devices. The cassettes / trays are made of standard medical gradematerials and do not incorporate any new technological characteristics.
PerformanceData:	Sterilization validation testing was performed to demonstrate Instru-SafeInstrument Protection System compatibility when used in an Amsco V-PRO LowTemperature Sterilization Systems with a legally marketed wrap or Aesculap rigidcontainer.
Conclusion:	Based upon intended use, performance data and technical information provided inthis pre-market notification, the Instru-Safe Instrument Protection Systemdescribed herein is substantially equivalent to the predicate device [Instru-SafeInstrument Protection System (K133015)].

{15}------------------------------------------------

Image /page/15/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 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-2006	8	2
IN-2681	13	0.64
IN-2682	13	0.89
IN-2683	13	1.39
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-2950	12	4.1
IN-3030	34	9.5
IN-4000	20	3.2
IN-4003	30	3.25
IN-4010	10	1.98
IN-5009	8	5
IN-5401	6	2
IN-5401-02	2	1
IN-5401-03	2	1
IN-5401-08	8	3.2
IN-5401-12	12	3.25
IN-6103	2	2.15
IN-6105	2	2.15
IN-6110	3	2.15
IN-6203	2	2.75
IN-6205	2	2.75
IN-6210	2	2.75
IN-6240	2	2.75
IN-6303	2	3.28
IN-6305	2	3.28
IN-6310	2	3.28
IN-6403	2	3.28
IN-6405	2	3.28
IN-6410	2	3.28

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 11

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized, 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, with a clean and professional look.

IN-6500	30	12.5
IN-7010	2	2
IN-7012	1	1.07
IN-7020	30	8.5
IN-7030	30	10
IN-7032	2	1.1
IN-7073	10	5
IN-7120	45	11.25
IN-7123	45	12
IN-7130	45	13.5
IN-7140	45	14.5
IN-7150	8	1.9
IN-7153	6	1.7
IN-7220	45	14.5
IN-7223	10	9.2
IN-7230	45	14.5
IN-7234	45	14.5
IN-7240	45	14.5
IN-7250	45	14.5
IN-7252	25	8
IN-7260	45	14.5
IN-7273	10	6
IN-7274	30	8
IN-7322	45	14.5
IN-7323	45	14.5
IN-7343	45	14.5
IN-7344	1	4
IN-7360	45	14.5
IN-7423	45	14.5
IN-7452	10	8
IN-7453	10	8
IN-7540	45	14.5
IN-7560	45	14.5
IN-7644	45	14.5
IN-7723	15	7.18
IN-7724	15	7.2
IN-7725	10	9.5

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA

phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds arranged in a horizontal row. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

IN-7781	45	14.5
IN-7823	45	14.5
IN-7830	45	14.5
IN-7840	45	13.5
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-8615	2	5.8
IN-8616	2	5.8
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-8640	4	5.35
IN-8642	4	5.35
IN-8643	5	5.35
IN-8645	4	5.35
IN-8650	4	5.85
IN-8660	4	5.35
IN-8662	4	5.35
IN-8663	3	5.5
IN-8700	40	14
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-8860	15	8.75
IN-8862	30	10.5
IN-8863	45	14

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA

phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com

summermedicalusa.com
Page 0 of 11

Page 9 of 11

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of three blue diamonds arranged horizontally above the word "SUMMIT" in a stylized blue font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif blue font.

IN-8880	2	3.28
IN-8882	16	12.1
IN-8883	2	3.28
IN-8884	4	5.35
IN-8885	1	2.25
IN-8886	6	12.1
IN-8889	6	12.1
IN-8891-S	1	2
IN-8891-SI-12-S	1	2
IN-8891-SI-85-S	1	2
IN-8892	12	12.1
IN-8893	9	7.5
IN-8894	5	16.1
IN-8897	8	6
IN-8898	10	10.25
IN-8899	7	6.5
IN-8901	1	2.25
IN-8902-G2	22	17
IN-8903	15	13.25
IN-8904	22	17
IN-8907	7	12.5
IN-8931	1	2.4
IN-8932	9	9.5
IN-8933	3	3.75
IN-8936	6	11.5
IN-8937	16	14.5
IN-8938	8	12.5
IN-8939	10	11.6
IN-8940	5	5.18
IN-8942	11	10
IN-8943	1	2.7
IN-8944	6	4.7
IN-8945	2	5.18
IN-8946	9	6.1
IN-8980	20	9.5
IN-8982-01	17	9.5
IN-8983-01	16	9.5

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 10 of 11

{19}------------------------------------------------

Image /page/19/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, arranged horizontally. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

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
IN-9999-162-S	2	5.8
IN-9999-168-S	2	5.8
IN-9999-172-S	2	5.8
IN-9999-178-S	2	5.8

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).