(22 days)
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation.
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for root canal lavage and debridement and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hypochlorite in water.
The provided text describes a 510(k) premarket notification for a dental product, "PULPDENT Sodium Hypochlorite Solution." The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving specific acceptance criteria in the context of device performance metrics often seen in AI/ML or diagnostic device submissions.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document.
Here's an analysis based on the provided text, indicating where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Composition | Substantially equivalent to predicate products for composition (5.25% sodium hypochlorite in water). | Stated to be 5.25% sodium hypochlorite in water, same as predicate. |
| Intended Use | Substantially equivalent to predicate products for intended use (root canal lavage and debridement, irrigant for root canal instrumentation). | Stated to be used for root canal lavage and debridement, and as an irrigant for root canal instrumentation, same as predicate. |
| Safety | Considered safe in concentrations less than 7.5% and when applied to intact tissue, referencing the American Dental Association Council on Accepted Dental Therapeutics. | Implied to meet safety standards by being 5.25% sodium hypochlorite, which is below the 7.5% threshold. |
| Effectiveness | Aqueous solutions of 2.5% and 5% sodium hypochlorite reportedly equally effective in dissolving pulpal debris when used as root canal irrigants, referencing the American Dental Association Council on Accepted Dental Therapeutics. | Implied to be effective by being a 5.25% sodium hypochlorite solution, which is similar to the "equally effective" concentrations mentioned. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a test set or experimental data in the way a clinical study would for a diagnostic device. The "study" here is primarily a literature review and comparison to predicate devices.
- The "data provenance" is a citation from the American Dental Association Council on Accepted Dental Therapeutics, which is a published professional standard rather than specific patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" and thus no ground truth established by experts in the context of a clinical performance study. The "ground truth" for safety and effectiveness is derived from established dental literature and consensus, as cited from the American Dental Association.
4. Adjudication method for the test set
- Not applicable. No test set or direct expert adjudication of results is mentioned.
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 device is a chemical solution, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a chemical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's safety and effectiveness relies on expert consensus and established scientific literature regarding sodium hypochlorite solutions in dentistry, as promulgated by the American Dental Association Council on Accepted Dental Therapeutics. It is not based on pathology, outcomes data, or a specific patient-level ground truth generated for this submission.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device. The basis for safety and effectiveness comes from general scientific and clinical knowledge of the substance.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this submission.
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EXHIBIT 7
RESPONSE TO SMDA OF 1990
SIOUK SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262
PULPDENT Sodium Hypochlorite Solution DEVICE NAME:
PREDICATE DEVICE: Premier Hypogen Union Broach Sodium Hypochlorite Solution
DESCRIPTION AND INTENDED USE:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hvpochlorite solution used for root canal lavage and debridement and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hvochlorite in water.
COMPARISON WITH PREDICATE PRODICTS:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is substantially equivalent in composition and intended use as the predicate products. Please see Exhibit 5 for the entire companison.
SAFETY AND EFFECTIVENESS:
According to the American Dental Association Council on Accepted Dental Therapeutics: "Sodium hypochlorite solution has a solvent action on pulp tissue and organic debris, and is used for irrigation of root canals. Aqueous solutions of 2.5 percent and 5 percent sodium hypochlorite are reportedly equally effective in dissolving pulpal debris when used as root canal irrigants." Sodium hypochlorite solution is considered safe in concentrations less than 7.5 percent and when applied to intact tissue. Please see Exhibit 6 for the entire citation.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and a curved line representing its tail. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle above the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 1996
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272
K962743 Re : Pulpdent Sodium Hypochlorite Solution Trade Name: Regulatory Class: Unclassified Product Code: KJJ July 9, 1996 Dated: July 15, 1996 Received:
Dear Mr. Berk:
We have reviewed your Section 510(k) notification of incent to we have reviewed your Becced. bove and we have determined the market the acvroutially equivalent (for the indications for use stated in the enclosure) to devices marketed in interestate commerce prior to May 28, 1976, the enactment date of the Commerce prior comments or to devices that have been Medical Beviet 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with Subscancearly agturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMF) regulacion (2) Crod and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertify such asbampelonin regulatory action. In addition, FDA may publish further announcements concerning your device in may publical Register. Please note: this response to your the rederal Regioner ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . prematier noctricacion on under sections 531 through 542 of obligation you might have the Electronic Product Radiation the Act for devices under one acceal Laws or Regulations.
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Page 2 - Mr. Berk
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
Olin S. E. Jr.
Timothy a. Ulatowski
Timothy A. Ulatowsk Acting Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Suprom Device Name: PUL P D EN T Hypochlo Indications For Use:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation. ased to: 12735 EN 000100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE): |
|---|
| --------------------------------------------------------- |
| (Division Sign-Off) | Susan Keasey |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K96162743 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
N/A