(476 days)
No
The device description and summary of performance studies indicate a traditional, disposable medical device without any mention of AI or ML capabilities.
Yes
The device is used to evacuate air and/or fluid from the chest cavity or mediastinum, re-establish lung expansion, restore breathing dynamics, and collect autologous blood for reinfusion, all of which are therapeutic interventions aimed at treating a patient's condition.
No
Explanation: The device is used to evacuate fluid/air and for autotransfusion, which are therapeutic and restorative functions, not diagnostic ones.
No
The device description explicitly states it is a "sterile, single use, disposable device" that "mimics a traditional '3 Bottle Systems'" and is a "closed thoracic drainage system (chest drain and catheter together)". This clearly describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to evacuate air and/or fluid from the chest cavity and facilitate the collection and reinfusion of autologous blood. This is a therapeutic and procedural function, not a diagnostic one.
- Device Description: The device is described as a closed thoracic drainage system used to restore the chest to a more normalized condition. While it collects blood, the purpose is for reinfusion (treatment), not for analyzing the blood to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device performing any tests or analyses on the collected fluid or blood to provide diagnostic information about the patient's condition.
- No Mention of IVD-related activities: The description of performance studies focuses on device performance, biocompatibility, sterility, and stability, which are typical for medical devices, but not specifically for IVDs which would involve validation of analytical and clinical performance for diagnostic purposes.
In summary, the device is designed for therapeutic and procedural purposes related to chest drainage and blood management, not for providing diagnostic information.
N/A
Intended Use / 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.
Product codes
CAC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity, pleural spaces, mediastinum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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 Corporation
40 Continental Drive
Merrimack, NH 03054 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 3011175548 |
| Contact Person: | Robin Mulvey
Principal Regulatory Affairs Specialist
Tel: 603.864.5424
Fax: 973.629.1325
email: robin.mulvey@getinge.com |
| Date Prepared: | May 13, 2020 |
| Device Information: | |
| Trade Name(s): | Auto transfusion (ATS) Chest Drains:
Ocean Water Seal Chest Drain
Oasis Dry Suction Water Seal Chest Drain
Express 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 are
classified as Class II devices in the US
according to 21 CFR 868.5830 |
4
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
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".
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.
Intended Use
The Auto transfusion (ATS) Chest Drains are intended to evacuate air and/or fluid from the chest cavity (pleural spaces or mediastinum).
5
GENTIC F
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
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.
6
GENTING
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
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.
7
GETINGE *
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
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.
8
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
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 | Ocean
Water Seal
Chest Drain | Oasis Dry
Suction
Water Seal
Chest
Drains | Express Dry
Seal Chest
Drain |
|--------------------------------------------------|------------------------------------|-------------------------------------------------------|------------------------------------|
| 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
9
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
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 Drains
Major Materials | Ocean Auto
transfusion
Drain | Oasis Ocean
Auto transfusion
Drain | Express
Ocean Auto
transfusion
Drain |
|-----------------------------------------------------------------------------|------------------------------------|------------------------------------------|-----------------------------------------------|
| Acrylonitrile butadiene
styrene (ABS) | √ | √ | √ |
| Polyvinyl Chloride (PVC) | √ | √ | √ |
| TPE/TPR
Thermoplastic Elastomers
(TPE)/ Thermoplastic
Rubber (TPR) | √ | √ | √ |
| High Density Polyethylene
(HDPE) | √ | √ | √ |
| Low-Density Polyethylene
(LDPE) | √ | √ | √ |
Table 2: Major Materials of Construction
10
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
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)
300CC
Acrylonitrile butadiene styrene and
Polysulfone | Filter, Screen, Blood Recovery Unit
(BRU) 300CC
Acrylonitrile butadiene styrene and
Polysulfone | Same as Predicate. |
| Sub Assembly, Drain, Blood Recover Unit
(BRU)
Polyisoprene, Low-Density Polyethylene,
Cryolite acrylic, Acrylonitrile butadiene
styrene, High Density Polyethylene | Sub Assembly, Drain, Blood Recover
Unit (BRU), Ocean
Polyisoprene, Low-Density
Polyethylene, Cryolite acrylic,
Acrylonitrile butadiene styrene, High
Density Polyethylene | Same as Predicate. |
| Hanger, Drain, Flexible
Nylon , white | Hanger, Drain, Flexible
Nylon, white | Same as Predicate. |
| Stand, Chest Drain, Universal
Acrylonitrile butadiene styrene (ABS), white | Stand, Chest Drain, Universal
Acrylonitrile butadiene styrene (ABS),
white | Same as Predicate. |
| Dye Ball - white W/blue dye
Polypropylene ball | Dye Ball - white W/blue dye
Polypropylene ball | Same as Predicate. |
| Spring, Manual Vent Valve
302 stainless steel | Spring, Manual Vent Valve
302 stainless steel | Same as Predicate. |
| Plug, Dye Carrier W/blue Dye
Porous Hydrophilic Polyethylene | Plug, Dye Carrier W/blue Dye
Porous Hydrophilic Polyethylene | Same as Predicate. |
| Seal, Manual Vent Valve | Seal, Manual Vent Valve | Same as Predicate. |
| Ball, 1/2" white
polypropylene
homopolymer resin | Ball, 1/2" white polypropylene
homopolymer resin | Same as Predicate. |
| Stopper, Tethered
Kraton, color: gray | Stopper, Tethered
Kraton, color: gray | Same as Predicate. |
| Drain Body/ Insert/ Back
Acrylonitrile butadiene styrene (ABS),
White | Drain Body/ Insert/ Back
Acrylonitrile butadiene styrene (ABS),
White | Same as Predicate. |
| Drain Cover (Front)
Acrylonitrile butadiene styrene (ABS) clear | Drain Cover (Front)
Cryo, Cryolite | Same as Predicate
with the exception of
a change to material
from Cryo, Cryolite
to Acrylonitrile
butadiene 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 Predicate
with the exception of a
change in tubing
length. |
| Sub Assembly Stopcock Suction Line
Low-Density Polyethylene (LDPE). | Sub Assembly Stopcock Suction Line
302 stainless steel spring | The strain relief was
changed from a 302
stainless steel spring
to a Low-Density
Polyethylene (LDPE). |
| Strain Relief, Patient Tube 6
Low-Density Polyethylene (LDPE) | Strain Relief, Patient Tube 6
302 stainless steel spring | The strain relief was
changed from 302
stainless steel spring
to a Low-Density
Polyethylene (LDPE). |
| Ink Jet Printing | Silk Screen Printing Ink | Same as Predicate
with the exception of a
change from Silk
Screen printing to
Inkjet 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. Red
Transprint | Label, Blank, Color Stripe, Rub. Red
Transprint | Same as Predicate
with the exception of a
change to transprint
specification. |
| Instruction For Use (IFU)
40 pound offset | Instruction For Use (IFU)
50 pound offset | Same as Predicate with
the exception of
change to 40 pound
offset. |
| DEHP Label
Label, Blank, 6.5 X 3.75 | Label not present in Predicate device | DEHP label added to
device . |
| Iconic IFU
Label,Flat,Blank,WT,6.5X4.625 | Not present in Predicate device | The addition of an
Iconic IFU. |
| Pouch, Nylon/Tyvek | Bag, Breather | The change did not
impact the products
ability to meet sterile
barrier, presentation
into a sterile field,
sterilization of the
finished device, or
packaging and
handling requirements. |
11
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
12
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
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.
13
GENTIC F
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
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).