The HEMOBAG™ is a blood circulating storage reservoir designed to collect anticoagulated whole blood salvaged from extracorporeal circuits after the patient has been disconnected from the circuit. When used in connection with the TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a reservoir for circulating and hemoconcentrating blood in a closed circuit recovery loop.

Device Description

The HEMOBAG™ Blood Salvage Device is a storage reservoir for blood that can be held, circulated and hemoconcentrated. It is designed for use in salvaging anticoagulated whole blood from extracorporeal circuits. When used in conjunction with a TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a hemoconcentrating reservoir for use in a closed circuit recovery loop for removal of excess plasma water and low molecular weight solutes. The richly concentrated, anticoaqulated, autologous whole blood is then quickly made available to the patient for gravity transfusion.

The HEMOBAG™ is designed with a universal (1/4" – 3/8″) stepped connector on the arterial infusion port to allow lines of varying sizes to be attached to the bag. The inlet and outlet ports of the bag are designed with quick connect/disconnect ¼" connectors to mate with the TS3 Tubing set for fluid delivery to and from the hemoconcentrator. The HEMOBAG™ is equipped with a needleless port for ease of access. The HEMOBAG™ has been designed with a spike port to facilitate gravity transfusion. A baffle has been positioned inside the bag to allow the blood from the hemoconcentrator to enter the bag and circulate toward the top of the bag and down again to the outlet port allowing proper mixing and flow during hemoconcentration.

AI/ML Overview

The provided text details a 510(k) summary for the HEMOBAG™ Blood Salvage Device. It includes information on safety and effectiveness testing.

Here's an analysis of the provided information against your requested criteria:

Study Information Pertaining to the HEMOBAG™ Blood Salvage Device

Acceptance Criteria Category	Details and Reported Device Performance
1. Acceptance Criteria & Reported Performance	Safety Acceptance Criteria: - Device successfully passes biological evaluation (biocompatibility testing) per ANSI/AAMI/ISO 10993, Vol. 4 for limited exposure medical devices with circulating blood contact. - Cellular damage (change in hematocrit, platelet depletion, white blood cell count, plasma free hemoglobin, and calculated % hemolysis) introduced by the device during blood circulation should not be statistically significant compared to a predicate device. - Acceptable hematological parameters are maintained during testing. Effectiveness Acceptance Criteria: - Device must accommodate and hold up to 2000ml of anticoagulated whole blood. - Device must function as a reservoir for hemoconcentration by ultrafiltration. - Device must allow circulation of fluid at a rate of 300-500ml/minute for 10-15 minutes (design specification for blood). - Device must maintain structural integrity (no leaks/failure) when overfilled with warm water by 10-20% and hung for 2 hours, and during water circulation at 2000 ml/minute for 2 hours (stressed conditions). - Rounded corners and baffle must facilitate proper mixing and flow during hemoconcentration. Reported Device Performance: - Biocompatibility: The device successfully passed all specified biocompatibility tests. - Cellular Trauma (Safety): The difference in cellular damage between the HEMOBAG™ and the predicate device was statistically insignificant. Hematological parameters were acceptable. - Holding Capacity (Effectiveness): The device successfully held up to 2000ml of fluid. - Circulation & Reservoir Function (Effectiveness): The device successfully circulated fluid at a rate of 2000 ml/minute for 2 hours (exceeding blood circulation design targets of 300-500ml/min for 10-15 min). It withstood overfilling and hanging. - Mixing and Flow (Effectiveness): Rounded corners and interior baffle allow for proper mixing and flow.
2. Sample Size & Data Provenance (Test Set)	Safety Testing: - A single evaluation was performed comparing the HEMOBAG™ to a predicate device using "anticoagulated bovine whole blood." The specific number of test runs or samples is not explicitly stated, but it implies a direct comparison on a test circuit. - Data provenance: In vitro testing using bovine blood. Country of origin not specified, but likely within the US given the submission to the FDA. Retrospective or prospective is not applicable as it is laboratory testing. Effectiveness Testing: - The functionality was "successfully tested." This implies a series of tests, but the exact number of HEMOBAG™ devices or test runs is not specified. - Data provenance: In vitro testing using warm water. Country of origin not specified. Retrospective or prospective is not applicable.
3. Number & Qualifications of Experts for Ground Truth (Test Set)	Not applicable. This device's testing involves direct measurement of physical and biological parameters (e.g., cell counts, fluid volume, flow rates) and in vitro biocompatibility tests, not subjective expert assessment of images or clinical outcomes. The "ground truth" is established by laboratory measurements and adherence to specified performance metrics.
4. Adjudication Method (Test Set)	Not applicable, as there's no subjective assessment requiring adjudication. The evaluation relies on quantitative measurements.
5. MRMC Comparative Effectiveness Study	No. This device is a blood salvage and storage reservoir, not an AI diagnostic tool or imaging device that would typically undergo an MRMC study. The comparison made was between the device's impact on blood components and a predicate device.
6. Standalone (Algorithm Only) Performance Study	Yes, in a sense. The entire testing described focuses on the device's standalone performance (i.e., how it performs as a physical product) without a human operator's variable input being the primary focus of the evaluation. There is no algorithm, so "algorithm only" is not applicable, but the device's functionality and safety were assessed independently.
7. Type of Ground Truth Used	- Safety Testing: Laboratory measurements of cellular depletion, hemolysis (plasma free hemoglobin, calculated % hemolysis), hematocrit changes, platelet depletion, and white blood cell count. Comparison to a predicate device served as a comparative benchmark. Successful passage of standardized biocompatibility tests. - Effectiveness Testing: Direct measurement of fluid containment, circulation rates, and structural integrity under stress, against defined performance specifications.
8. Sample Size for Training Set	Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. Ground Truth for Training Set	Not applicable, as there is no training set for a physical device.

Summary of Device Performance to Acceptance Criteria:

The HEMOBAG™ successfully met all stated acceptance criteria for both safety and effectiveness based on the described in vitro studies.

Safety: It passed biocompatibility tests and demonstrated statistically insignificant cellular damage compared to a predicate device under stressed circulation conditions.
Effectiveness: It successfully held and circulated fluid at or above specified rates under stressed conditions, confirming its functionality as a storage and hemoconcentration reservoir.

Summary

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JUN 2 3 2003

K 031150

510(k) SUMMARY

SAFETY TESTING

The sterile HEMOBAG™ was subjected to biological evaluation (biocompatibility testing) using the guidelines provided in ANSI/AAMI/ISO 10993, Vol. 4 for limited exposure medical devices that have contact with circulating blood. The device successfully passed all of these tests.

The HEMOBAG™ was evaluated to determine whether or not it introduced more trauma to the blood than the predicate device. The evaluation was done by determining the cellular depletion and hemolysis of anticoaqulated bovine whole blood that had been circulated through the HEMOBAG™ at a rate of approximately 1.2 liters per minute for a 1-hour period. An identical evaluation was performed on the anticoagulated bovine whole blood that had been circulated through the predicate device in the same manner. The results of these tests proved that the difference between the amount of cellular damage noted in the blood that had been circulated through the HEMOBAG™ and that which had been circulated through the predicate device was statistically insignificant. Cellular damage was measured by change in hematocrit, platelet depletion, white blood cell count, plasma free hemoglobin and calculated % hemolysis. Blood in the test circuits was evaluated and found to have demonstrated acceptable hematological parameters during the test period. Since the test parameters used represent a scenario that is far worse than parameters that will be seen in proper clinical use, this device is considered safe with respect to cellular damage and hemolysis when used under abnormal stressful conditions.

EFFECTIVENESS

The function and purpose of this device is to accommodate and hold up to 2000ml of anticoagulated whole blood salvaged from an extracorporeal circuit after the patient has been removed. The device also functions as a reservoir for the same blood as it is hemoconcentrated by ultrafiltration for ultimate gravity transfusion to the patient. The HEMOBAG™ has been designed using materials and processes that will allow the flexible bag to hold up to 2000ml of fluid circulating at a rate of 300 – 500ml per minute for a period of approximately 10 – 15 minutes. The functionality of the HEMOBAG™ was successfully tested by overfilling the bag with warm water by 10 -- 20% and allowing the bag to hang for a period of 2 hours and then water to circulate through the bag at a rate of 2000 ml per minute for a period of 2 hours. Since the test parameters used represent a scenario far worse than those seen in clinical use, the device is considered effective with respect to its ability to serve as a reservoir for holding, circulating and hemoconcentrating up to 2000ml of anticoagulated whole blood. The rounded corners and baffle inside the bag allow mixing and proper flow of the blood through the HEMOBAG™ during hemoconcentration.

APPENDIX D

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2003

Global Blood Resources, LLC Mr. Keith Samolyk, CCP President & CEO 998 Windsor Avenue Windsor, CT 06096

Re: K031150

Trade/Device Name: HEMOBAGTM Regulation Number: 21 CFR 870.4400 Regulation Name: Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: April 7, 2003 Received: April 10, 2003

Dear Mr. Samolyk:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Keith A. Samolyk, CCP.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Afgealngpl

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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JUN 2 3 2003

INTENDED USE

C. Wyndham for B. Zuckerman

ivision of Cardiovascular Devices

KO31150 510(k) Number

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.