(123 days)
K0011312
Not Found
No
The device description focuses on the mechanical and pneumatic aspects of a hyperbaric chamber. There is no mention of AI, ML, or any software-driven analysis or decision-making processes.
Yes
The device is a hyperbaric oxygen chamber used to treat various medical conditions listed under "Intended Use / Indications for Use," indicating its purpose is to provide therapy.
No
The text describes a hyperbaric oxygen therapy chamber, which is a treatment device, not a diagnostic one. It lists conditions the device is used to treat, but it does not perform any analysis or detection of medical conditions.
No
The device description clearly details a physical hyperbaric oxygen chamber made of aluminum alloy and steel, with pneumatic controls, safety valves, and a retractable bed. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various medical conditions using hyperbaric oxygen therapy. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is a hyperbaric chamber, a physical structure designed to enclose a patient and administer oxygen at increased pressure. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the living organism).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide a therapeutic environment for the patient.
N/A
Intended Use / Indications for 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
Product codes
CBF
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.
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
Not Found
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 results of bench and clinical testing indicates that the new device is as safe and effective as the predicate device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0011312.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
-
- Equivalent legally marketed devices: Khrunichev BLKS-303 MK Monoplace Hyperbaric System, K0011312.
-
- 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
-
- 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.
-
- 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 | Khrunichev
BLKS-303MK
K011312. | 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 |
| Blowing and compression | l/min | 400 | 400 |
| 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 |
6. Substantial Equivalence Chart
2
| Parameters | Units | Khrunichev
BLKS-303MK
K011312. | Khrunichev
BLKS-307 |
|-------------------------------------------------------|-------|------------------------------------------------|--------------------------|
| Built-In-Breathing System | | Optional | Optional |
| Standards and Regulatory
Documents
Compliant 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 Pressure
Vessels Code | Vessels Code |
| | | National Ministry of
Healthcare Certificate | National Ministry of |
| | | Healthcare Certificate | National Fire Protection |
| | | National Fire Protection
Code | 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.
3
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.
4
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
5
Indications for Use
510(k) Number (if known): K06
Device Name: BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM
Indications For Use:
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 .
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
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