Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a system for organizing and protecting medical devices during sterilization, with no mention of AI or ML capabilities.

Therapeutic

No
The device is used to organize and protect other medical devices during sterilization, not to provide therapy itself. Its function is to facilitate the sterilization process for other devices.

Diagnostic

No
Explanation: The device is a system for organizing and protecting other medical devices during sterilization. It is not intended to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "System cassettes" used to organize and protect other medical devices, indicating a physical hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used to "organize and protect other medical devices that are sterilized by a healthcare provider" and to "allow sterilization of the enclosed medical devices." This describes a device used in the sterilization and handling of surgical instruments, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
- Being used in a laboratory setting for testing

The device's function is related to the sterilization and organization of medical instruments, which falls under the category of medical devices used in healthcare procedures, but not specifically for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 pre-vacuum steam 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.

Autoclave Sterilization Parameter

Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

Summit 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.

Lumen size of instrumentation validated includes:

Summit Cassette Model	Minimum Inside Diameter	Maximum Length	Number of Lumens
IN-8823-CF	3mm	400mm	4
IN-8823-CF	3mm	200mm	2
IN-2880	1mm	76mm	2
IN-2880	3mm	177mm	1
IN-6105	5mm	241mm	1
IN-2681	1mm	65mm	1
IN-2681	3mm	200mm	1
IN-7823	1mm	400mm	17

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

Not Found

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

healthcare provider

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)

Not Found

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.

Not Found

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

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 symbol resembling a stylized caduceus or a representation of human figures.

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

March 13, 2014

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

Re: K133015

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: February 12, 2014 Received: February 14, 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. Ilsting 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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely yours.

http://www.fda.gov/MedicalDeviccs/Resourcesfor You/Industry/default.htm.

Erin I. Keith, M.S. Acting 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 large, bold, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three black diamonds arranged horizontally.

Indications for Use Statement

Page of

510(k) number: Unknown, new submission - TBD K133015

Device Name: Instru-Safe® Instrument Protection System

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 pre-vacuum steam 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.

Autoclave Sterilization Parameter

Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

Summit 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F 2014.03.12 15

Prescription Use: (Per 21 CFR 801.109) OR

Over-The-Counter x

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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Indications for Use Statement

Page of

| Summit
Cassette Model | Minimum
Inside
Diameter | Maximum
Length | Number of
Lumens |
|--------------------------|-------------------------------|-------------------|---------------------|
| IN-8823-CF | 3mm | 400mm | 4 |
| IN-8823-CF | 3mm | 200mm | 2 |
| IN-2880 | 1mm | 76mm | 2 |
| IN-2880 | 3mm | 177mm | 1 |
| IN-6105 | 5mm | 241mm | 1 |
| IN-2681 | 1mm | 65mm | 1 |
| IN-2681 | 3mm | 200mm | 1 |
| IN-7823 | 1mm | 400mm | 17 |

Lumen size of instrumentation validated includes:

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/4/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in large, bold, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three black diamonds, arranged horizontally.

:

Indications for Use Statement

Attachment 1 - Device Models
Part Number	Maximum # of Instruments	Estimated Weight - Tray w/ instruments (lbs)
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-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-7012	1	1.07
IN-7032	2	1.1
IN-7150	8	1.9
IN-7153	6	1.7
IN-7223	10	9.2
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	25	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-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-8892-01	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 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 large, bold, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three black diamonds, arranged horizontally.

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

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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 large, bold, sans-serif font, with the word "medical" in a smaller font size underneath. Above the word "SUMMIT" are three diamond shapes, arranged horizontally. The logo is simple and modern, and the use of the diamond shapes suggests a sense of precision and accuracy.

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