· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Device Description

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

AI/ML Overview

This document describes a 510(k) premarket notification for Atrium Medical Corporation's Auto transfusion (ATS) Chest Drains, specifically the Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, and Express Dry Seal Chest Drain. The filing argues for substantial equivalence to previously cleared predicate devices (K043140 and K043582).

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics. This 510(k) submission is focused on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical trials.

The performance is implicitly described as being equivalent to the predicate devices and that the device "performs as well as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. No dedicated "test set" in the context of clinical performance evaluation is mentioned for the modified device. The document states, "There were no clinical studies of the modified device."
Data Provenance: Not applicable for a new clinical study. The submission relies on the established safety and performance of the predicate devices and extensive non-clinical testing of the modified devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a new clinical test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

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 device is an auto transfusion chest drain, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K043140 and K043582), as well as compliance with relevant voluntary standards and successful completion of non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. The device is not an AI/ML algorithm.

Summary of Acceptance Criteria and "Study" (Non-Clinical) Proving Equivalence:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. The "study" that proves this involves a comprehensive non-clinical assessment, outlined as follows:

Acceptance Criteria (Implied for Substantial Equivalence):

Same Intended Use: The modified devices must have the same indications for use as the predicate devices.
Similar Technological Characteristics: The modified devices must operate on the same fundamental scientific technology and have similar features. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
Similar Materials: The major materials of construction must be the same or demonstrably equivalent in terms of safety and biocompatibility.
Performance: The modified devices must perform as well as the predicate devices.
Safety: The risks associated with the intended use must be acceptable and compatible with a high level of protection of health and safety.

"Study" (Non-Clinical Testing) Proving Equivalence:

The document states that Atrium Medical's development process required the completion of the following non-clinical activities:

Specification Review: Ensuring the designs meet predefined criteria.
Performance Testing: Verifying the functional aspects of the device.
Biocompatibility Testing: Evaluating the device's interaction with biological systems (e.g., ISO 10993 series).
Sterility Testing: Confirming the device is sterile and maintains sterility.
Stability Testing: Assessing the device's ability to maintain its properties over time (shelf life).
Design Validation: Ensuring the device meets user needs and intended uses.

These non-clinical tests, along with compliance with voluntary standards (Section 9, though not provided in the excerpt), are the basis for demonstrating that the modified devices are safe and effective and perform as well as the predicate devices, thereby supporting the claim of substantial equivalence. The submission also relies on the low complaint rates and reportable events of the predicate devices over the last 5 years as evidence of acceptable clinical safety and performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 3, 2021

Atrium Medical Corporation Robin Mulvey Senior Regulatory Affairs Specialist 40 Continental Blvd. Merrimack, New Hampshire 03054

Re: K201305

Trade/Device Name: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: July 30, 2021 Received: August 4, 2021

Dear Robin Mulvey:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201305

Device Name

Auto transfusion (ATS) Chest Drains:

Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

Indications for Use (Describe)

· Evacuate air and/or fluid from the chest cavity or mediastinum.

· Help re-establish lung expansion and restore breathing dynamics.

Chest Drain Auto transfusion (ATS)

To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

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)

区 Prescription Use (Part 21

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

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Atrium Medical Corporation Premarket Notification Traditional 510(k) Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain and Express Dry Seal Chest Drain

Section 5 510(K) Summary

Auto transfusion (ATS) Chest Drains 510(k) summary prepared in accordance with 21 CFR part 807.92

General information:

Submitter's name and address:	Atrium Medical Corporation40 Continental DriveMerrimack, NH 03054
Registration Number:	3011175548
Contact Person:	Robin MulveyPrincipal Regulatory Affairs SpecialistTel: 603.864.5424Fax: 973.629.1325email: robin.mulvey@getinge.com
Date Prepared:	May 13, 2020
Device Information:
Trade Name(s):	Auto transfusion (ATS) Chest Drains:Ocean Water Seal Chest DrainOasis Dry Suction Water Seal Chest DrainExpress Dry Seal Chest Drain
Common/Generic Name:	apparatus, Auto transfusion
Classification Name:	Auto transfusion apparatus
Regulation Number:	21 CFR 868.5830
Product Code:	CAC (Anesthesiology Device Panel)
Device Class:	The Auto transfusion (ATS) Chest Drains areclassified as Class II devices in the USaccording to 21 CFR 868.5830

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Predicate Device Information:

Atrium's Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drains, Oasis Dry Suction Water Seal Chest Drains and Express Dry Seal Chest Drains are substantially equivalent in function and intended use to the Express Chest Drain and Oasis Chest Drain (K043140) and Ocean Water Seal Chest Drain (K043582).

Device Description

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

Intended Use

The Auto transfusion (ATS) Chest Drains are intended to evacuate air and/or fluid from the chest cavity (pleural spaces or mediastinum).

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GENTIC F

Indications for Use

· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics. Chest Drain Auto transfusion (ATS)

To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Intended User/Operator

The primary intended users of the Auto transfusion Chest Drains; Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain and Express Dry Seal Chest Drain are surgeons, physicians, or nurses. Specifically, the primary intended users are chest medicine physicians, including but not limited to surgeons (cardiothoracic, general trauma, hepatobiliary, urology and other trained and qualified to treat conditions in the thorax requiring drainage), interventional physicians (pulmonology, radiology, anesthesiology, emergency medicine, critical care medicine, pain medicine and others trained and qualified to treat conditions in the thorax requiring drainage), physicians' assistants and certified nurse advanced practitioners or nurses who have been trained in the theoretical, technical, and clinical aspects of the use the devices.

Intended Use Environment

Auto transfusion Chest Drains; Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain and Express Dry Seal Chest Drain are used in a sterile environment (e.g. the surgical suite) or in a non-sterile environment (e.g. the Intensive Care Unit (ICU) or the Emergency Room (ER)) where a local sterile environment for procedures can be created.

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GENTING

Intended Patient

The target patient population is patients who need fluid and/or air evacuated from the chest cavity (pleural spaces or mediastinum). The actual choice of a specific drainage product is determined by the clinical indications and contraindications and the specific requirements of each patient's anatomy and physiologic condition as clearly described in the respective guides accompanying each

device. The choice of device is at the sole discretion of the physician in charge of that patient.

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GETINGE *

Example Auto transfusion Drain

Image /page/7/Picture/3 description: The image shows an Atrium Ocean water seal chest drain. The device has multiple chambers labeled A, B, C, and D with numerical scales for measuring fluid levels. The scales range from 0 to 2000, with finer gradations for more precise measurements.

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Technological characteristics:

Atrium's Auto transfusions (ATS) Chest Drains have the same technology and attributes as the predicate devices (K043140 and K043582).

Auto transfusions (ATS)Chest Drains Features	OceanWater SealChest Drain	Oasis DrySuctionWater SealChestDrains	Express DrySeal ChestDrain
Air Leak Monitor	√	√	√
Collection Chamber	√	√	√
Dry Suction Regulator		√	√
Easy-to-Grip Handle	√	√	√
In-Line Connector	√	√	√
Manual High Negativity Vent	√	√	√
Multi-Position Hangers	√	√	√
Needleless Access Port	√	√	√
Patient Connector	√	√	√
Patient Pressure Float Ball	√	√	√
Patient Tube	√	√	√
Patient Tube Clamp	√	√	√
Positive Pressure Release Valve	√	√	√
Suction Control Chamber	√
Suction Monitor Bellows		√	√
Suction Port	√	√	√
Swing Out Floor Stand	√	√	√
Vacuum Indicator			√
Water Seal Chamber	√	√
Ampoule, Water, 45ml		√
Prefilled Syringe, 30ml			√

Table 1: Technological Characteristics

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Major Materials of Construction:

Atrium's Auto transfusions (ATS) Chest Drains have the same Major Materials of Construction as the predicate devices (K043140 and K043582).

Auto transfusions (ATS)Chest DrainsMajor Materials	Ocean AutotransfusionDrain	Oasis OceanAuto transfusionDrain	ExpressOcean AutotransfusionDrain
Acrylonitrile butadienestyrene (ABS)	√	√	√
Polyvinyl Chloride (PVC)	√	√	√
TPE/TPRThermoplastic Elastomers(TPE)/ ThermoplasticRubber (TPR)	√	√	√
High Density Polyethylene(HDPE)	√	√	√
Low-Density Polyethylene(LDPE)	√	√	√

Table 2: Major Materials of Construction

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Table 3 below demonstrates the equivelancy of the Auto transfusion (ATS) Chest drains subject of this submission against the Auto transfusion (ATS) Chest Drains subject of the predicate submissions K043140 and K043582.

Table 3: Summary Comparison to Predicates K043140 and K043582

Device Component	PREDICATES:K043140 K043582	Comparison
Filter, Screen, Blood Recovery Unit (BRU)300CCAcrylonitrile butadiene styrene andPolysulfone	Filter, Screen, Blood Recovery Unit(BRU) 300CCAcrylonitrile butadiene styrene andPolysulfone	Same as Predicate.
Sub Assembly, Drain, Blood Recover Unit(BRU)Polyisoprene, Low-Density Polyethylene,Cryolite acrylic, Acrylonitrile butadienestyrene, High Density Polyethylene	Sub Assembly, Drain, Blood RecoverUnit (BRU), OceanPolyisoprene, Low-DensityPolyethylene, Cryolite acrylic,Acrylonitrile butadiene styrene, HighDensity Polyethylene	Same as Predicate.
Hanger, Drain, FlexibleNylon , white	Hanger, Drain, FlexibleNylon, white	Same as Predicate.
Stand, Chest Drain, UniversalAcrylonitrile butadiene styrene (ABS), white	Stand, Chest Drain, UniversalAcrylonitrile butadiene styrene (ABS),white	Same as Predicate.
Dye Ball - white W/blue dyePolypropylene ball	Dye Ball - white W/blue dyePolypropylene ball	Same as Predicate.
Spring, Manual Vent Valve302 stainless steel	Spring, Manual Vent Valve302 stainless steel	Same as Predicate.
Plug, Dye Carrier W/blue DyePorous Hydrophilic Polyethylene	Plug, Dye Carrier W/blue DyePorous Hydrophilic Polyethylene	Same as Predicate.
Seal, Manual Vent Valve	Seal, Manual Vent Valve	Same as Predicate.
Ball, 1/2" whitepolypropylenehomopolymer resin	Ball, 1/2" white polypropylenehomopolymer resin	Same as Predicate.
Stopper, TetheredKraton, color: gray	Stopper, TetheredKraton, color: gray	Same as Predicate.
Drain Body/ Insert/ BackAcrylonitrile butadiene styrene (ABS),White	Drain Body/ Insert/ BackAcrylonitrile butadiene styrene (ABS),White	Same as Predicate.
Drain Cover (Front)Acrylonitrile butadiene styrene (ABS) clear	Drain Cover (Front)Cryo, Cryolite	Same as Predicatewith the exception ofa change to materialfrom Cryo, Cryoliteto Acrylonitrilebutadiene styrene(ABS) clear
Device Component	PREDICATES:K043140 K043582	Comparison
Tubing Set, Auto Connect (A/C),69	Tubing Set, Auto Connect (A/C),80	Same as Predicatewith the exception of achange in tubinglength.
Sub Assembly Stopcock Suction LineLow-Density Polyethylene (LDPE).	Sub Assembly Stopcock Suction Line302 stainless steel spring	The strain relief waschanged from a 302stainless steel springto a Low-DensityPolyethylene (LDPE).
Strain Relief, Patient Tube 6Low-Density Polyethylene (LDPE)	Strain Relief, Patient Tube 6302 stainless steel spring	The strain relief waschanged from 302stainless steel springto a Low-DensityPolyethylene (LDPE).
Ink Jet Printing	Silk Screen Printing Ink	Same as Predicatewith the exception of achange from SilkScreen printing toInkjet printing.
Tape, 1/2 Smooth Crepe Color: beige	Tape, 1/2 Smooth Crepe Color:beige	Same as Predicate.
Shipper, Corrugated	Shipper, Corrugated	Same as Predicate.
Label, Blank, Color Stripe, Rub. RedTransprint	Label, Blank, Color Stripe, Rub. RedTransprint	Same as Predicatewith the exception of achange to transprintspecification.
Instruction For Use (IFU)40 pound offset	Instruction For Use (IFU)50 pound offset	Same as Predicate withthe exception ofchange to 40 poundoffset.
DEHP LabelLabel, Blank, 6.5 X 3.75	Label not present in Predicate device	DEHP label added todevice .
Iconic IFULabel,Flat,Blank,WT,6.5X4.625	Not present in Predicate device	The addition of anIconic IFU.
Pouch, Nylon/Tyvek	Bag, Breather	The change did notimpact the productsability to meet sterilebarrier, presentationinto a sterile field,sterilization of thefinished device, orpackaging andhandling requirements.

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Atrium Medical Corporation Premarket Notification Traditional 510(k) Auto transfusion (ATS) Chest Drains: `,
Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest
Drain and Express Dry Seal Chest Drain

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Non-clinical tests:

The Auto transfusion (ATS) Chest Drains comply with the voluntary standards identified in section 9 of this submission. Atrium Medical's development process required that the following activities be completed during the development of the current configuration of the Ocean Water Seal, Oasis Dry Suction Water Seal and Express Dry Seal Chest Drains.

· specification review
· performance testing
· biocompatibility testing
· sterility testing
· stability testing
design validation

Clinical tests:

There were no clinical studies of the modified device.

The Auto transfusion (ATS) Chest Drain products are designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users. The risks associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. The clinical evaluation of the product is sufficient to demonstrate both clinical safety and performance of the Auto transfusion (ATS) Chest Drains based on the articles reviewed, and from the low complaint rates and reportable events over the last 5 years. Post-market experience indicates that complications rates in clinical use constitute risks commensurate with the state of the art as indicated by the clinical evaluation.

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GENTIC F

Conclusion:

The Ocean Water Seal, Oasis Dry Suction Water Seal and Express Dry Seal Chest Drains are similar to the predicate devices in the intended use and the fundamental scientific technology of the device.

The design verification and validation testing established that the Ocean Water Seal, Oasis Dry Suction Water Seal and Express Dry Seal Chest Drains are safe and effective and performs as well as the predicate devices.

Based upon the information submitted in this Traditional 510(k) premarket notification, Ocean Water Seal, Oasis Dry Suction Water Seal and Express Dry Seal Chest Drains are substantially equivalent to the currently marketed Express Chest Drain and Oasis Chest Drain (K043140) and Ocean Water Seal Chest Drain (K043582).

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).