(50 days)
To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim.
The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child mouth-co-mouth vehiclate the operator's mouth from the victim's body fluids. The CPR ISO-SHIELD has a shield barrier, a plastic bite block/air tube with walve which is placed between the victim's teeth. The operator blows into the tube and uses victim's ceeth. The victim's exhalation is acceptable of their breath escaping around the valve and between the shield and their face. The large surface area of the barrier, 40 Square inides reduces the risk of vomitus coming in contact with the operator's face side of the shield. Two plastic grips are added to the ISO-SHIELD, attached to the valve housing below the barrier on the victim's side. This allows the operator to handle the device under the protective the operator of ize the transfer of contamination to the top surface. These grips also have memory which should help lift " surface. "Incoc getim's face after the operator releases his mouth. ISO-SHIELD has a polyethylene material. ISO-SHIELD uses a silicone rubber flapper design for the valve. This results in less valve. This is claires by the operator blowing into the valve as compared to Microshield. The ISO-SHIELD has two plastic grips attached to the valve housing.
The provided text is a 510(k) summary for the "Rondex CPR Iso-Shield" and does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical trial or a performance study for complex medical devices would.
However, based on the information provided, I can extract the relevant details that align with the questions you've asked, focusing on the equivalence demonstration:
1. Table of Acceptance Criteria and Reported Device Performance
The submission argues for substantial equivalence by comparing its design and safety/effectiveness features to predicate devices. While not presented as a formal table with quantitative acceptance criteria, the document implicitly uses the performance of predicate devices as the benchmark for acceptance.
| Feature/Criterion (Implicit) | Predicate Device Performance (Microshield, Res-Cue Key) | Rondex CPR Iso-Shield Performance | Meets Criterion? |
|---|---|---|---|
| Operator protection from body fluids (mouth-to-mouth technique) | Yes | "reducing the risk of the operator's mouth coming in contact with body fluids" | Yes |
| Ability for victim to breathe spontaneously | Yes (Microshield) | Yes, when the shield is released from the victim's face | Yes |
| Efficacy of ventilation (sealing and ventilation effectiveness) | Equivalent to predicate (Microshield) | Equivalent to Microshield on adult Laerdal and child manikin | Yes |
| Material of shield barrier | Vinyl (PVC?) for Microshield, Polyethylene for Res-Cue Key | Polyethylene (4 mil) | Yes (Different but equivalent or superior) |
| Valve design | Flapper valve (Res-Cue Key), unspecified (Microshield) | Silicone rubber flapper design (similar to Res-Cue Key) | Yes |
| Easy handling/reduced contamination risk | No specific mention for grips | Two plastic grips to position/remove without touching top surface; helps lift from face | Yes (Improved feature) |
| Facilitates exhalation | No specific mention (Microshield, Res-Cue Key) | Aids lifting from face, especially if nose is pinched closed | Yes (Improved feature) |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the simulated testing performed on manikins.
- Sample Size: "an adult Laerdal manikin" and "an Anne and Armstrong child manikin Timmy - Southly". This implies a very small sample size of two manikins.
- Data Provenance: The testing was likely conducted by Rondex Products, Inc. (the manufacturer) in the USA. The data is prospective in the sense that the company conducted these specific tests for the 510(k) submission, even though it wasn't a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications for establishing a "ground truth" for the manikin tests. It's likely that the assessment of "effective resuscitation" and "equivalent" ventilation was made by company personnel or a consultant based on standard CPR manikin testing protocols.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears to be a direct comparison or assessment of performance against the predicate.
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
- No. This device is a manual CPR shield, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. As mentioned above, this is a manual medical device, not an algorithm. Standalone performance of an algorithm is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" used for the manikin testing appears to be based on simulated performance metrics (effective resuscitation, sealing, ventilation effectiveness) as established by generally accepted protocols for evaluating CPR devices on manikins. It's not pathology, expert consensus in a clinical setting, or outcomes data. It's an engineering and functional performance assessment.
8. The Sample Size for the Training Set
- This concept is not applicable here as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable as the device is not an AI algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2022
Rondex Products, Inc. Gene Baldwin President P.O. Box No. 1829 Rockford, Illinois 61110
Re: K981169
Trade/Device Name: Rondex CPR Iso-Shield Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing valve Regulatory Class: Class II Product Code: CBP
Dear Gene Baldwin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 19, 1998. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code CBP.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact James J. Lee, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-8463, James.J.Lee@fda.hhs.gov.
Sincerely,
Image /page/0/Picture/9 description: The image shows the text "James J. Lee -S" in a large, bold font. The text is arranged horizontally, with the name "James J. Lee" appearing first, followed by a hyphen and the letter "S". The font is sans-serif and the color is black. The background is white.
James J. Lee, Ph.D. Division Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of a bird or eagle with three heads, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1998
Mr. Gene R. Baldwin Rondex Products, Inc. P.O. Box No. 1829 Rockford, IL 61110
Re: K981169 CPR Shield Regulatory Class: II (two) Product Code: 73 LYM Dated: March 25, 1998 March 30, 1998 Received:
Dear Mr. Baldwin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) ... inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gene R. Baldwin
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
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K981169/A '
Page of
K981169 510 (k) NUMBER (IF KNOWN) :
DEVICE NAME : Rondex CPR Iso-Shield
INDICATIONS FOR USE:
To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim.
FDA/CDRH/ODE/DMC
15 Apr 98 12 45
RECEIVED
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
. Puzic
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K981169
SK-15
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MAY | 9 1998
RONDEX PRODUCTS, INC. P.O. Box 1829 Rockford, Illinois May 4, 1994 phone: 815-226-0452 contact: Gene R. Baldwin Device Name: CPR ISO-SHIELD Common Name: CPR Shield Predicate Devices: Microshield a • Res-Cue Key b .
510K SUMMARY OF SAFETY AND EFFECTIVENESS
The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child mouth-co-mouth vehiclate the operator's mouth from the victim's body fluids.
The CPR ISO-SHIELD has a shield barrier, a plastic bite block/air tube with walve which is placed between the The operator blows into the tube and uses victim's teeth. victim's ceeth. The victim's exhalation is acceptable of their breath escaping around the valve and between the shield and their face.
Design characteristics: The large surface area of the besign onataoquare inches reduces the risk of vomitus barrier, 40 Square inides of the shield and coming in contact with the operator's face side of the shield. Two plastic grips are added to the ISO-SHIELD, attached to the valve housing below the barrier on the victim's side. This allows the operator to handle the device under the protective the operator of ize the transfer of contamination to the top These grips also have memory which should help lift " surface. surface. "Incoc getim's face after the operator releases his mouth.
The technological characteristics of the device differ somewhat from Microshield. ISO-SHIELD has a polyethylene somewhat from from Microshield uses vinyl (PVC ?). Res-Cue Key appears to use polyethylene material.
ISO-SHIELD uses a silicone rubber flapper design for the This results in less This is similar to Res-Cue Key. valve. valve. This is claires by the operator blowing into the valve as compared to Microshield.
The ISO-SHIELD has two plastic grips attached to the valve Microshield and Res-Cue Key do not have this housing. The grips allows the operator to position and feature. remove the shield without touching the top surface. Touching the top surface increases the risk of contamination being the cop bad to the blowing surface where the operator puts his lips. The grips also help release the shield from the victim's face after the operator releases his mouth.
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page 2 RONDEX PRODUCTS, INC.
SAFETY & EFFECTIVENESS TO OTHER MARKETED PRODUCTS:
The victim can breathe spontaneously, if they have the The victim can breathe spontaneously, II oney and the device is in
ability, without operator assistance when the victim's face. ability, without operator assistance whon the victimes face.
place and the shield is released from the victim's face.
The shield Same as Microshield.
The CPR ISO-SHIELD has a means to help lift the shield The CPR ISO-SHIELD has a means to facilitate exhalation barrier away from victim's face to laciried. Canada on top of
especially if the operator pinches the nose closed on top of especially if the operator pinches the nose offer this.
the shield. Microshield and Res-Cue Key do not offer this.
Device can be handled beneath the protective shield barrier, Device can be handled beneath the protective one areas against
the victim's side, to increase safety to the operator's face side the victim's side, to increase salety to the operator's face side, contamination being transferred to the operater of the this.
Effective resuscitation was achieved using the technique Effective resuscitation was achieved using on an adult Laerdal
similar to mouth resuscitation on an adult Laerdal similar to mouth-to-mouth resulscroabson Sealing and Anne and Armstrong child manikin Timmy - Southly
ventilation effectiveness were equivalent to Microshield.
Ambu's ISO SHIELD has a 4 mil polyethylene shield barrier.
I material man al mil (polyethylene?) material for ISO SHIELD has a 4 mil polyethylene?) material for the a I mil (polyechylche. , is very thin and shield barrier. shield barrier. This thickness, I mis, victim's or one is high risk of it tearing on the Vioram of the 11 mil vinyl material.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).