INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM by SUMMIT MEDICAL, INC.

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 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The 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

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Instru-Safe Instrument Protection System." This document describes the device, its intended use, and lists various models. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Based on the provided text, I can only provide the following information:

Device Description:

Trade/Device Name: Instru-Safe Instrument Protection System
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Tray
Regulatory Class: II
Product Code: KCT
Manufacturer: Summit Medical Incorporated

Intended Use/Indications for Use:

"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 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility."

Sterilization Validation:

The device models were validated with specified rigid containers for:

Sterrad 100S Standard Cycle
Sterrad 100NX Standard Cycle

Lumen Claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles:

4 Stainless steel lumens with 3mm inner diameter × 400mm length (All appropriate sized models listed in Table 1 with the exception of IN-2681)
2 Stainless steel lumens with 3mm inner diameter × 200mm length
1 Stainless steel lumens with 3mm inner diameter × 200mm length (IN-2681)
1 Stainless steel lumens with 1mm inner diameter × 65mm length

Missing Information:

The document does not contain any of the following information explicitly related to acceptance criteria or a study proving the device meets them:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. (This device is a physical sterilization tray, not an AI software, so this section is not applicable).
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done. (Not applicable for a physical device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set. (Not applicable for a physical device, as there is no "training set" in the AI/ML sense).
How the ground truth for the training set was established. (Not applicable).

To obtain the missing information, one would need to review the actual submission documents (e.g., test reports, validation studies) that were provided to the FDA by Summit Medical Incorporated for K140289. The letter provided here is merely the FDA's decision letter based on that submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The bird is positioned within a circular border. Encircling the bird within the border is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 27, 2014

Summit Medical Incorporated Ms. Nicole Dove QA/RA Manager 815 Northwest Parkway, Suite 100 St. Paul. MN 55121

Re: K140289

Trade/Device Name: Instru-Safe Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: May 29, 2014 Received: June 2, 2014

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely vours.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FFOR

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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Image /page/2/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with three black 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 use of black and white gives it a professional look.

Indications for Use Statement

Page 1 of 4

510(k) number: K140289

Device Name: Instru-Safe® Instrument Protection System

Indications for Use:

The following sterilization trays were validated with the corresponding rigid containers:

. Sterrad 100S Standard Cycle

1Continued on the comparedassette Model------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comment country of consider con from the drive and the cases of the cases of the cases of the cases of the cases of the cases of the cases of the cases of the cases of the caontainer Model
-------------------------IN_2872	MAAA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------INTE INSA LENGLES AMALES OFF E-------------------------------------------------------------------------------------------------------------------------------------------------------------------	1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------* INAAAC

Sterrad 100NX Standard Cycle �

Summit Cassette Model	Aesculap Container Model
IN-8823-AE	*JM444
IN-6105	*JM440

Validated by Summit Medical for use in Sterrad 100S Standard Cycle and Sterrad 100NX Standard Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims.

Lumen claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles:

4 Stainless steel lumens with 3mm inner diameter × 400mm length	All appropriate sized models listed in Table 1 with the exception of IN-2681
2 Stainless steel lumens with 3mm inner diameter × 200mm length
1 Stainless steel lumens with 3mm inner diameter × 200mm length	IN-2681
1 Stainless steel lumens with 1mm inner diameter × 65mm length

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter	X
------------------	---

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth

Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=20005404 90, cn=Sreekanth Gutala -S Date: 2014.06.25 15:35:48 -04'00'

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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 a bold, sans-serif font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three black diamonds arranged horizontally. The logo is simple and modern, and the use of black and white gives it a professional look.

Table 1 - Device Models
-------------------------	--	--	--	--	--	--

Part Number	Maximum # of Instruments	Estimated Weight - Tray w/ instruments (Ibs)
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	રેણ	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-5401	б	2
IN-5401-02	2	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IN-5401-03	2	l
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-7012	l	1.07
IN-7032	2	1.1
IN-7150	8	1.9
IN-7153	б	1.7
IN-7223	10	9.2

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

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Image /page/4/Picture/1 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with three black 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 use of black and white gives it a professional look.

IN-7224	15	7.2
IN-7225	10	9.5
IN-7723	15	7.18
IN-7724	15	7.2
IN-7725	10	9.5
IN-7823	18	4
IN-7940	20	13.25
IN-8240	20	13.5
IN-8420	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-8660	4	5.35
IN-8662	4	5.35
IN-8663	4	5.35
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-8863	30	10.5
IN-8880	45	14
IN-8882	2	3.28
IN-8883	16	12.1
IN-8884	2	3.28
IN-8885	1	2.25
IN-8886	6	12.1
IN-8889	6	12.1
IN-8891-S	1	2
IN-8891-S1-12-S	1	2
IN-8891-SI-85-S	1	2
IN-8892-01	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	22	17
IN-8903	15	13.25
IN-8904	22	17
IN-8907	7	12.5
IN-8945	2	5.18
IN-8946	9	6.1
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
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
| 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 large, bold letters, with three black diamonds above it. Below the word "SUMMIT" is the word "medical" in smaller letters.

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

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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).