Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical sterilization container system and the summary does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Therapeutic

No.

This device is a sterilization container system designed to hold other medical devices for sterilization and maintain their sterility, not to treat a disease or condition itself.

Diagnostic

No

The device is a sterilization container system, not a diagnostic device. Its purpose is to sterilize and maintain the sterility of other medical devices, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical container system made of materials like anodized aluminum and PTFE, intended for enclosing other medical devices for sterilization. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is a "reusable sterilization container system... intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." This describes a device used in the sterilization process of other medical devices, not a device used to perform tests on samples taken from the human body.
Device Description: The description focuses on the physical components and function of the container system for sterilization.
Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Detecting diseases or conditions
- Using reagents or assays

The device's function is to facilitate the sterilization and maintenance of sterility for other medical devices, which falls under the category of medical device accessories or sterilization equipment, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Aesculap Sterilcontainer System is a reusable sterilization container system (conssisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

A combined maximum load validated for all container configurations is 25lbs.

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

KCT

Device Description

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

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)

The SterilContainer with PrimeLine Pro Lid was fully validated for pre-vacuum steam and IUSS sterilization cycles. The validations were conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. The following performance testing has been completed to ensure substantial equivalence. Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size.

Performance Properties
Sterilization Efficacy: Testing demonstrated a 6 log reduction and a sterility assurance level (SAL) of 10-6 using the biological (BI) overkill method and half-cycle validation.
Whole Package Microbial Aerosol Challenge: After exposure to a defined amount of aerosol microorganisms contents maintained sterility.
Event Related Sterility Maintenance (30, 180, and 365 days): The test reports demonstrated that the SterilContainer with PrimeLine Pro Lid consistently maintained sterility of the contents after processing followed by a 30, 180, and 365 day event related storage under conditions which simulate hospital sterile package handling and storage conditions as long as the barrier is not compromised.
Mechanical Cleaning (Protein Analysis): The study results validate that the mechanical cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than 6.4µg/cm² per device.
Mechanical Cleaning (Hemoglobin Analysis): The study results validate that the mechanical cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a hemoglobin level of less than 2.2 µg/cm² per device.
Manual Cleaning (Protein Analysis): The study results validate that the manual cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than 6.4µg/cm² per device.
Manual Cleaning (Hemoglobin Analysis): The study results validate that the manual cleaning instructions were effective in removing gross amounts of soil from the SterilContainer with PrimeLine Pro Lid to a protein level of less than 2.2 µg/cm² per device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sterilization Efficacy: 6 log reduction and a sterility assurance level (SAL) of 10-6
Mechanical Cleaning (Protein Analysis): protein level of less than 6.4µg/cm² per device.
Mechanical Cleaning (Hemoglobin Analysis): hemoglobin level of less than 2.2 µg/cm² per device.
Manual Cleaning (Protein Analysis): protein level of less than 6.4µg/cm² per device.
Manual Cleaning (Hemoglobin Analysis): protein level of less than 2.2 µg/cm² per device.

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.

Primeline Lid (K073168)

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.

Sterilcontainer System (K792558), Rigid Container System (K944864), and the SterilContainer System for Flash Indications (K053389), and SterilContainer System for Pre-Vac Steam. Immediate Use Steam, and EtO Sterilization (K112671).

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2017

Aesculap, Inc. Lisa Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K172850

Trade/Device Name: SterilContainer with PrimeLine Pro Lid Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 24, 2017 Received: October 25, 2017

Dear Lisa Boyle:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172850

Device Name

SterilContainer with PrimeLine Pro Lid

Indications for Use (Describe)

The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters	PrimeLime Pro Container
Lid with JP050 - Lid Size	Solid Base to be used
with Lid	Max No. of Lumens
Lumen Configuration
Immediate Use (Non porous)
270°F Temp, 3 min. Exposure
No stacking recommended	1/2 size Lid
(298 x281 x36)
Art. No. JP121 - JP125	JK340 (4-1/4 in height)
JK341 (5-1/2 in height)
JK342 (6 in height)
JK344 (8 in height)
JK346 (10-1/2 in height)	Immediate Use - Non Porous:
No lumens, a hinged device,
and a knurled (irregular
surface) device.
Immediate Use (porous)
270°F Temp, 4 min. Exposure
No stacking recommended	3/4 size Lid
(465 x 281 x 36)
Art. No. JP111 - JP115	JK740 (4-1/4 in height)
JK741 (5-1/2 in height)
JK742 (6 in height)
JK744 (8 in height)	Immediate Use - Porous:
1 SS lumen with 3mm I.D. x
400mm L and a hinged device.
Prevacuum Dry Time Study
270°FTemp, 4min.Exposure, 30 min.
Dry Time
Stacking should not exceed 16-18"
height	Full size Lid
(588 x 281 x 36)
Art. No. JP101 - JP105	JK440 (4-1/4 in height)
JK441 (5-1./2 in height)
JK442 (6 in height)
JK444 (8 in height)
JK446 (10-1/2 in height)
Sterilization Cycle	Lid Size	Perforated Base to be
used with Lid
	1/2 size Lid
(298 x281 x36)
Art. No. JP121 - JP125	JN340 (41/2 in height)
JN341 (51/2 in height)
JN342 (6 in height)
JN344 (8 in height)
JN346 (101/2 in height)
Prevacuum Dry Time Study
270°FTemp, 4min.Exposure, 30 min.
Dry Time
Stacking should not exceed 16-18"
height	3/4 size Lid
(465 x 281 x 36)
Art. No. JP111 - JP115	JN740 (4-1/4 in height)
JN741 (5-1/2 in height)
JN742 (6 in height)
JN744 (8 in height)
	Full size Lid
(588 x 281 x 36)
Art. No. JP101 - JP105	JN440 (4-1/4 in height)
JN441 (5-1/2 in height)
JN442 (6 in height)
JN444 (8 in height)
JN446 (10-1/2 in height)

Table 2: Steam and IUSS Cycle Compatible Accessories

Accessories	Steam and IUSS
Stainless Steel baskets,
basket lids, and dividers	Yes
Instrument Organization System (Silicone and Stainless Steel racks,
brackets, holders, and clamps)	Yes
Silicone mats	Yes
Stainless Steel racks, trays, holders, clamps, brackets, and platforms	Yes

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■ Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) SUMMARY (as required by 21 CFR 807.92)

SterilContainer with PrimeLine Pro Lid November 10, 2017

| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 291671- |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa Boyle
610-984-9274 (phone)
610-791-6882 (fax) |
| TRADE NAME: | SterilContainer with PrimeLine Pro Lid |
| COMMON NAME: | Sterilization Container |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |

PREDICATE DEVICES

Primary Predicate : Primeline Lid (K073168) Reference Devices: Sterilcontainer System (K792558), Rigid Container System (K944864), and the SterilContainer System for Flash Indications (K053389), and SterilContainer System for Pre-Vac Steam. Immediate Use Steam, and EtO Sterilization (K112671).

DEVICE DESCRIPTION

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

INDICATIONS FOR USE

The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS

5

(Immediate Use Steam Sterilization) sterilization modalities. The SterilContainer System includes accessories such as silicone mats, baskets, trays, and racks.

A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters	PrimeLime Pro Container
Lid with JP050 - Lid Size	Solid Base to be used
with Lid	Max No. of Lumens
Lumen Configuration
Immediate Use (Non porous)
270°F Temp, 3 min. Exposure
No stacking recommended	½ size Lid
(298 x281 x36)
Art. No. JP121 - JP125	JK340 (4-1/4 in height)
JK341 (5-1/2 in height)
JK342 (6 in height)
JK344 (8 in height)
JK346 (10-1/2 in height)	Immediate Use - Non Porous:
No lumens, a hinged device,
and a knurled (irregular
surface) device.
Immediate Use (porous)
270°F Temp, 4 min. Exposure
No stacking recommended	¾ size Lid
(465 x 281 x 36)
Art. No. JP111 - JP115	JK740 (4-1/4 in height)
JK741 (5-1/2 in height)
JK742 (6 in height)
JK744 (8 in height)	Immediate Use - Porous:
1 SS lumen with 3mm I.D. x
400mm L and a hinged device.
Prevacuum Dry Time Study
270°FTemp, 4min.Exposure, 30 min.
Dry Time
Stacking should not exceed 16-18"
height	Full size Lid
(588 x 281 x 36)
Art. No. JP101 - JP105	JK440 (4-1/4 in height)
JK441 (5-1./2 in height)
JK442 (6 in height)
JK444 (8 in height)
JK446 (10-1/2 in height)
Sterilization Cycle	Lid Size	Perforated Base to be
used with Lid
Prevacuum Dry Time Study
270°FTemp, 4min.Exposure, 30 min.
Dry Time
Stacking should not exceed 16-18"
height	½ size Lid
(298 x281 x36)
Art. No. JP121 - JP125	JN340 (41/2 in height)
JN341 (51/2 in height)
JN342 (6 in height)
JN344 (8 in height)
JN346 (101/2 in height)
	¾ size Lid
(465 x 281 x 36)
Art. No. JP111 - JP115	JN740 (4-1/4 in height)
JN741 (5-1/2 in height)
JN742 (6 in height)
JN744 (8 in height)
	Full size Lid
(588 x 281 x 36)
Art. No. JP101 - JP105	JN440 (4-1/4 in height)
JN441 (5-1/2 in height)
JN442 (6 in height)
JN444 (8 in height)
JN446 (10-1/2 in height)

Table 1: Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid

Table 2: Steam and IUSS

Cycle Compatible Accessories

Accessories	Steam and IUSS
Stainless Steel baskets,
basket lids, and dividers	Yes
Instrument Organization System (Silicone and Stainless Steel racks,
brackets, holders, and clamps)	Yes
Silicone mats	Yes
Stainless Steel racks, trays, holders, clamps, brackets, and platforms	Yes

TECHNOLIGICAL CHARACTERISTICS (compared to predicates)

The SterilContainer with PrimeLine Pro Lid is made from anodized aluminum (AMg1). The only difference between the subject device and the predicate lid is material of the lid. The original Primeline Lid (K073168) is constructed of a plastic polymer, but uses the exact same integrated PTFE filter and retention plate system of the subject SterilContainer with PrimeLine Pro Lid. This new lid is manufactured from the same aluminum type material that is used for other Aesculap SterilContainer Lids (K112671/K053389/K792258).

6

The SterilContainer with PrimeLine Pro Lid is compatible for use with pre-vacuum steam and IUSS sterilization which are the cycles that the Primeline Lid (K073168) was cleared for use with (steam and flash). Aesculap's Sterilization Container System was cleared for use in pre-vacuum steam and pre-vacuum IUSS among other sterilization modalities.

The SterilContainer with PrimeLine Pro Lid is offered in variety of colors and sizes (full, 3/4, and half).

| Device/
System | Aesculap
SterilContainer
w/ PrimeLine
Pro Lid | Aesculap
SterilContainer
w/Aluminum
Lid and
PrimeLine Lid | Aesculap
SterilContainer
with Primeline
Lid | Aesculap
SterilContainer
(Flash) | Aesculap
PriMed Rigid
Container
System | Aesculap
Container
System |
|---------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------|-------------------------------------------------|---------------------------------|
| 510(k) | Pending | K112671 | K073168 | K053389 | K944864 | K792558 |
| Sterilization
Modalities | Pre-vac steam,
Immediate
Use Pre-vac
steam | Pre-vac steam,
Immediate Use
steam | Pre-vac steam,
Immediate Use
Pre-vac steam | Immediate Use
steam | Gravity
steam, High-
vacuum
steam, EO | Pre-vac,
Steam, EtO |
| Material | Anodized
Aluminum | Anodized
Aluminum/Radel
R | Anodized
Aluminum/Radel
R | Anodized
Aluminum | Anodized
Aluminum/
JADEX | Anodized
Aluminum |
| Worst case
Vent to
Volume Ratio | .50 | .41 | .49 | .68 | .59 | Not Available |
| Filter | Reusable filter | Single Use
Paper Filter,
Single Use
Polypropylene
Filter, Reusable
filter | Reusable filter | Single Use
Paper Filter | Single Use
Paper filter | Single Use
Paper Filter, |
| Shelf-life/
Barrier | 30,180, and
365 days
(event related) | 360 days (event
related) | 360 days (event
related) | N/A (24 hr
barrier) | Not defined | Not defined |
| Reuse testing | 2,200 uses (lid
and filter) | 2,200 uses (lid
and filter) | 2,200 uses (lid
and filter) | 100 cycles
minimum | 100 cycles
minimum | 100 cycles
minimum |
| Max total
weight | 25 pounds | 25 pounds | 35 pounds | 35 pounds | 25 pounds | 35 pounds |

PERFORMANCE DATA

The SterilContainer with PrimeLine Pro Lid was fully validated for pre-vacuum steam and IUSS sterilization cycles. The validations were conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory. The performance testing demonstrates substantial equivalence to the predicate devices. The following performance testing has been completed to ensure substantial equivalence. Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size.

7

Performance Properties	Results
Sterilization Efficacy	Testing demonstrated a 6 log reduction and a sterility
assurance level (SAL) of 10-6 using the biological (BI)
overkill method and half-cycle validation.
Whole Package Microbial
Aerosol Challenge	After exposure to a defined amount of aerosol
microorganisms contents maintained sterility.
Event Related Sterility
Maintenance (30, 180, and
365 days).	The test reports demonstrated that the SterilContainer with
PrimeLine Pro Lid consistently maintained sterility of the
contents after processing followed by a 30, 180, and 365
day event related storage under conditions which simulate
hospital sterile package handling and storage conditions as
long as the barrier is not compromised.
Mechanical Cleaning
(Protein Analysis)	The study results validate that the mechanical cleaning
instructions were effective in removing gross amounts of
soil from the SterilContainer with PrimeLine Pro Lid to a
protein level of less than 6.4µg/cm² per device.
Mechanical Cleaning
(Hemoglobin Analysis)	The study results validate that the mechanical cleaning
instructions were effective in removing gross amounts of
soil from the SterilContainer with PrimeLine Pro Lid to a
hemoglobin level of less than 2.2 µg/cm² per device.
Manual Cleaning (Protein
Analysis)	The study results validate that the manual cleaning
instructions were effective in removing gross amounts of
soil from the SterilContainer with PrimeLine Pro Lid to a
protein level of less than 6.4µg/cm² per device.
Manual Cleaning
(Hemoglobin Analysis)	The study results validate that the manual cleaning
instructions were effective in removing gross amounts of
soil from the SterilContainer with PrimeLine Pro Lid to a
protein level of less than 2.2 µg/cm² per device.

CONCLUSION

The SterilContainer with PrimeLine Pro Lid is substantially equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed predicate device.