The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

Air or gas embolism .
Carbon monoxide poisoning and carbon monoxide poisoning complicated by . cyanide poisoning
Clostridial myositis and myonecrosis .
Crush injury, compartment syndrome, and other acute traumatic ischemias .
Decompression sickness .
Enhanced healing of selected problem wounds .
Exceptional blood loss anemia .
Necrotizing soft tissue infections .
. Ostcomvelitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis) .
Skin grafts and flaps (compromised) .
Thermal burns .
Intracranial abscess .

Device Description

The system body is a hermetic cylindrical chamber, which consists of a welded hermetic shell and a quick-to-open cover, made of the AMg6 -ASME Code Case 2403 aluminum alloy. The cover lock ring is made of the SB-211 A 92024 material. The hyperbaric oxygen chamber is installed on a base, which is made of carbon steel, with four wheel castors attached to the base bottom. It can be moved within a treatment room if necessary. A control panel is located atop of on the pressure chamber, actuating pneumatic aggregates of the pressure system pneumatic system which are located under the chamber body. A patient's ingress/egress is performed by means of a retractable chamber bed that is wheeled out of the pressure chamber on a portable gurney, which is attached to the chamber at the time the patient is placed in and out of the chamber. The pressure system overall dimensions BI.KS-307-"Khrunichev" without the gurney: length - 100 in, width - 48 in, height - 70.9 in. The pressure system total weight BLKS-307-"Khrunichev" - 1102 lbs. Chamber pressure control is achieved by means of knobs and tumbler switches of a pneumatic control panel located atop of the chamber. Both the rates of pressurization and depressurization are variable to provide patient's comfort while in confined space and with regards to his/her individual tolerance to pressure rate change. The panel is equipped with an emergency decompression push button, which enables fast treatment session termination and egress of a patient in case of an emergency situation. If pressure inside the chamber exceeds maximal operating level of 43.5 PSI, two pressure-relief valves installed on the pressure chamber shell will open. This provides for the patient and personnel safety and prevents the chamber structure damage. In order to exclude possible electric spark formation in an oxygen atmosphere in case of transition of an accumulated electrostatic potential from a patient to the chamber shell, an antistatic bracelet is provided. The bracelet is put on a patient hand or foot. The system is equipped with a grounding cable, which is connected to the treatment room grounding system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, independent clinical trials with formal acceptance criteria for device performance. Therefore, many of the requested categories (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of regulatory submission.

The "acceptance criteria" here are essentially the comparison points and their values that demonstrate the new device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study. Instead, it presents a comparison table showing that the BLKS-307's performance characteristics are either similar to or improved upon the predicate device (BLKS-303MK), thus demonstrating substantial equivalence. The "acceptance criteria" are implied to be that the new device's parameters are within a clinically acceptable range or at least as good as the predicate.

Parameters	Units	Acceptance Criteria (Predicate: Khrunichev BLKS-303MK K011312)	Reported Device Performance (Khrunichev BLKS-307)
Internal Diameter	In (mm)	28.7 (730)	42.1 (1080)
Length	In (mm)	93.7 (2380)	90.4 (2300)
Internal Volume	Ft3 (m3)	26.9 (0.95)	56.5 (1.6)
Weight	Lbs (kg)	770 (320)	1102 (500)
Operating Pressure	ATA (Bar)	1 - 4	1 - 4
Compression / Decompression Rate	ATA/min (Bar/min)	0.05 - 0.25	0.05 - 0.25
Emergency Decompression Time from 4 to 1 ATA	Sec	60	90
Maximum Oxygen Consumption - Isopression (constant pressure) and decompression	l/min	50	52.5
Maximum Oxygen Consumption - Blowing and compression	l/min	400	400
Maximum Oxygen Consumption - One hour treatment	l (m3)	6000 (6)	9000 (9)
Lifetime	One-hour treatment sessions	10,000	10,000
Control System		Pneumatic	Pneumatic
Chamber Type		Monoplace	Monoplace
Electronic Patient Vitals and Environment Parameters Indication		Optional	Standard
Chamber Door Lock		Manual	Pneumatic
Material		Aluminum alloy/acrylic glass	Aluminum alloy/acrylic glass
Intercom Device		Standard	Standard
Built-In-Breathing System		Optional	Optional
Standards and Regulatory Documents Compliant to		FDA 510(k), ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code	ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code

Study Proving Acceptance Criteria (Substantial Equivalence):

The study proving the device meets the acceptance criteria (i.e., is substantially equivalent) is presented as a comparison between the new device (BLKS-307) and its predicate (BLKS-303MK). The document states: "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate device." and "After analyzing both bench and clinical testing data, it is the conclusion of Khrunichev State Research and Production Space Centre that the BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM is as safe and effective as the predicate device, and has few technological differences, thus it substantially equivalent to the predicate device."

This is a comparative study against the specifications and performance of an already legally marketed device, not an independent clinical trial with defined "acceptance criteria" for a new, unproven technology.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. This is a 510(k) submission based on substantial equivalence, primarily using a comparison of device specifications and "bench and clinical testing" results against a predicate device. There is no mention of a specific patient "test set" in the context of typical clinical trial methodology (e.g., a cohort of patients receiving treatment and being evaluated against an outcome). The "clinical testing" mentioned is likely in the context of device performance in a clinical setting rather than a formal human trial with a defined sample size for efficacy or safety endpoints.
Data Provenance: The manufacturer is Khrunichev State Research and Production Space Centre, located in Moscow. The precise origin of the "bench and clinical testing data" is not specified beyond this. It's not explicitly stated if it was retrospective or prospective, but given the nature of a 510(k) for a known technology, it's likely a combination of existing data, design validation, and performance testing rather than a new prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for diagnostic or AI devices is not relevant here. The evaluation is based on device specifications and performance characteristics compared to a predicate, and compliance with established standards (ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" in the sense of patient data requiring expert adjudication.

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 is not an AI/diagnostic device. It is a monoplace hyperbaric oxygen treatment system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the conventional sense. The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device and the hyperbaric oxygen therapy itself, as codified in standards and the UHMS Hyperbaric Oxygen Therapy Committee Report (1999) for its indications for use. The BLKS-307 demonstrates "substantial equivalence" to this established predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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K060739

JUL 21 2006

EXHIBIT 2 510(k) Summary

Khrunichev State Research and Production Space Centre 18, Novozavodskaya 121309 Moscow,

February 10, 2006

Contact: Gleb Mitinskiy

l . Identification of the Device: Proprietary-Trade Name: BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM Classification Names: CBF Hyperbaric Chamber Common/Usual Name: Hyperbaric Chamber
1. Equivalent legally marketed devices: Khrunichev BLKS-303 MK Monoplace Hyperbaric System, K0011312.
1. Indications for Use (intended use) The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UI·IMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- . Air or gas embolism
- . Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
- Clostridial myositis and myonecrosis .
- . Crush injury, compartment syndrome, and other acute traumatic ischemias
- Decompression sickness .
- . Enhanced healing of selected problem wounds
- . Exceptional blood loss anemia
- . Necrotizing soft tissue infections
- . Osteomyelitis (refractory)
- . Delayed radiation injury (soft tissue and bony necrosis)
- Skin grafts and flaps (compromised) .
- Thermal burns .
- . Intracranial abscess
1. Description of the Device: The system body is a hermetic cylindrical chamber, which consists of a welded hermetic shell and a quick-to-open cover, made of the AMg6 -ASME Code Case 2403 aluminum alloy. The cover lock ring is made of the SB-211 A 92024 material. The hyperbaric oxygen chamber is installed on a base, which is made of carbon steel, with four wheel castors attached to the base bottom. It can be moved within a treatment room if necessary. A control panel is located atop of on the pressure chamber, actuating pneumatic aggregates of the pressure system pneumatic system which are located under the chamber body. A patient's ingress/egress is performed by means of a retractable chamber bed that is wheeled out of the pressure chamber on a portable gurney, which is attached to the chamber at the time the patient

{1}------------------------------------------------

is placed in and out of the chamber. The pressure system overall dimensions BI.KS-307-"Khrunichev" without the gurney: length - 100 in, width - 48 in, height - 70.9 in. The pressure system total weight BLKS-307-"Khrunichev" - 1102 lbs. Chamber pressure control is achieved by means of knobs and tumbler switches of a pneumatic control panel located atop of the chamber. Both the rates of pressurization and depressurization are variable to provide patient's comfort while in confined space and with regards to his/her individual tolerance to pressure rate change. The panel is equipped with an emergency decompression push button, which enables fast treatment session termination and egress of a patient in case of an emergency situation. If pressure inside the chamber exceeds maximal operating level of 43.5 PSI, two pressure-relief valves installed on the pressure chamber shell will open. This provides for the patient and personnel safety and prevents the chamber structure damage. In order to exclude possible electric spark formation in an oxygen atmosphere in case of transition of an accumulated electrostatic potential from a patient to the chamber shell, an antistatic bracelet is provided. The bracelet is put on a patient hand or foot. The system is equipped with a grounding cable, which is connected to the treatment room grounding system.

1. Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate device.

Parameters	Units	KhrunichevBLKS-303MKK011312.	KhrunichevBLKS-307
Internal Diameter	In (mm)	28.7 (730)	42.1 (1080)
Length	In (mm)	93.7 (2380)	90.4 (2300)
Internal Volume	Ft3 (m3)	26.9 (0.95)	56.5 (1.6)
Weight	Lbs (kg)	770 (320)	1102 (500)
Operating Pressure	ATA (Bar)	1 - 4	1 - 4
Compression / DecompressionRate	ATA/min(Bar/min)	0.05 - 0.25	0.05 - 0.25
Emergency DecompressionTime from 4 to 1 ATA	Sec	60	90
Maximum Oxygen Consumption
Isopression (constantpressure) anddecompression	l/min	50	52.5
Blowing and compression	l/min	400	400
One hour treatment	l (m3)	6000 (6)	9000 (9)
Lifetime	One-hourtreatmentsessions	10,000	10,000
Control System		Pneumatic	Pneumatic
Chamber Type		Monoplace	Monoplace
Electronic Patient Vitals andEnvironment ParametersIndication		Optional	Standard
Chamber Door Lock		Manual	Pneumatic
Material		Aluminum alloy/acrylicglass	Aluminum alloy/acrylicglass
Intercom Device		Standard	Standard

6. Substantial Equivalence Chart

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Parameters	KhrunichevBLKS-303MKK011312.	KhrunichevBLKS-307
Built-In-Breathing System	Optional	Optional
Standards and RegulatoryDocumentsCompliant to	FDA 510(k)	ASME
	ASME	PVHO
	PVHO	NFPA 99
	NFPA 99	ISO 9001
	ISO 9001	ISO 13485
	ISO 13485	TUV
	TUV	National Pressure
	National PressureVessels Code	Vessels Code
	National Ministry ofHealthcare Certificate	National Ministry of
	Healthcare Certificate	National Fire Protection
	National Fire ProtectionCode	Code

7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of Khrunichev State Research and Production Space Centre that the BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM is as safe and effective as the predicate device, and has few technological differences, thus it substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

JUL 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Khrunichev State Research & Production Space Center C/O Mr. Daniel Kamm Regulatory Consultant Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K060739

Trade/Device Name: BLKS-307 Monoplace Hyperbaric Oxygen Treatment System Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: CBF Product Code: II Dated: June 15, 2006 Received: June 23, 2006

Dear Mr. Kamm:

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.

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 -Mr. Kamm

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 (QS) 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 (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K06

Device Name: BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM

Indications For Use:

Air or gas embolism .
Carbon monoxide poisoning and carbon monoxide poisoning complicated by . cyanide poisoning
Clostridial myositis and myonecrosis .
Crush injury, compartment syndrome, and other acute traumatic ischemias .
Decompression sickness .
Enhanced healing of selected problem wounds .
Exceptional blood loss anemia .
Necrotizing soft tissue infections .
. Ostcomvelitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis) .
Skin grafts and flaps (compromised) .
Thermal burns .
Intracranial abscess .

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mhald Mhalal for Annbrahan. 7/21/06

Number K060739

Page 1 of 1

Regulation Number and Section

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).