(315 days)
No
The device description and performance studies focus on mechanical components and their interaction with tissue, with no mention of data processing, algorithms, or learning capabilities.
Yes.
It is used to treat periodontal disease and for various surgical procedures, including soft tissue debridement and removal.
No
The device is an accessory for a piezosurgery system used for surgical procedures like osteotomy, osteoplasty, periodontal surgery, implantation, soft tissue debridement, and removal. It is explicitly indicated for treatment purposes, not for diagnosis.
No
The device description clearly outlines physical components made of stainless steel and PEEK, which are hardware. The performance studies also focus on the physical interaction and compatibility of these components.
Based on the provided information, the Contour P-Insert System (CPIS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses clearly describe surgical procedures performed directly on the patient's oral tissues (osteotomy, osteoplasty, periodontal surgery, implantation, soft tissue debridement). IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system of shafts and tips that physically interact with and modify oral tissues through mechanical vibrations. This is a surgical tool, not a device for analyzing biological samples.
- Anatomical Site: The device is used on "oral tissues," which are part of the living patient. IVD devices analyze samples taken from the patient.
- Performance Studies: The performance studies focus on the device's ability to perform surgical tasks (debriding tissue, removing bone) and its compatibility with other surgical equipment. They do not involve the analysis of biological samples or diagnostic metrics.
In summary, the CPIS is a surgical accessory used directly on the patient for treatment purposes, not a device used to analyze samples for diagnostic information.
N/A
Intended Use / Indications for Use
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:
-
Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
-
Soft tissue debridement and removal, particularly in intrabony lesions.
Product codes (comma separated list FDA assigned to the subject device)
DZI, ELC
Device Description
The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:
-
CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models 45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.
-
CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.
-
CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.
During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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 following tests were performed to determine the compatibility, functionality and performance of the CPIS. Five tests were performed on the subject device. As no written ISO or other consensus standards are applicable for the aforementioned tests, the peer-reviewed published literature and standard of care is cited as applicable in the study reports.
- Test Objective: Determination if the CPIS is compatible with the predicate device DSPS torque wrench accessory.
Outcome: The DSPS torque wrench fit, engaged, retained and easily disengaged from 100% of the CPIS samples.
Conclusion: This test demonstrates the compatibility of the DSPS torque wrench with the CPIS, and the Substantial Equivalence of the CPIS with the Predicate Device DSPS inserts due to the consistent fit of the DSPS torque wrench on the CPIS shaft square connector which is critical for proper function of the CPIS when connected to the DSPS.
Test Objective: Determination if the CPIS shaft proximal female threaded connector is compatible with the predicate DSPS handpiece distal end male threaded connector.
Outcome: No loosening of the CPIS inserts from the DSPS handpiece was observed in 100% of samples.
Conclusion: This test demonstrates the compatibility of the CPIS with the DSPS handpiece and the Substantial Equivalence of the CPIS with the Predicate Device DSPS, Specifically, the CPIS fits the Predicate Device DSPS handpiece distal male threaded connector and remains securely attached during use.
-
Test Objective: Determination if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's indications for use: soft tissue debridement and periodontal surgery
Outcome: For all samples in all groups, soft tissue was effectively debrided to expose all intended root surfaces.
Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "soft tissue debridement" and "periodontal surgery"; therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices. -
Test Objective: Determine if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's for use of: osteotomy. osteoplasty and periodontal surgery.
Outcome: For all samples in all groups, more than 1mm of bone, but less than 3mm of bone, was removed from around all Mock Resorptive Lesions as intended.
Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "osteotomy, osteoplasty, and periodontal surgery": therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices. -
Test Objective: Determine if the CPIS PEEK tips and the DSPS inserts damage tooth surfaces.
Outcome: In all cases, the CPIS QT PEEK tip did not cause any discernible tooth surface damage, while both DSPS inserts caused extensive tooth surface damage.
Conclusion: This test demonstrates that the CPIS is safe for use when in contact with tooth structure while the DSPS inserts tested are not safe for use in contact with tooth structure; therefore, the CPIS is superior to the Predicate Device DSPS inserts tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2020
Bennett Jacoby, DDS, MS, Inc. Bennett Jacoby President 77-6425 Kuakini Hwy, C2-84 Kailua Kona, Hawaii 96740
Re: K192033
Trade/Device Name: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: May 6, 2020 Received: May 11, 2020
Dear Bennett Jacoby:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192033
Device Name Contour P-Insert System (CPIS)
Indications for Use (Describe)
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:
-
Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
-
Soft tissue debridement and removal, particularly in intrabony lesions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
3
4. 510(k) SUMMARY
| 510(k) Sponsor & Manufacturer Information | |||
|---|---|---|---|
| 510(k) Sponsor & Manufacturer | Bennett Jacoby, DDS, MS, Inc. | ||
| Address | 77-6425 Kuakini Hwy, C2-84, Kailua-Kona, HI 96740 | ||
| Telephone | 731 451 0213 | ||
| bjacobyddsms@gmail.com | |||
| 510(k) Summary Preparation Date | June 4 2020 |
| 510(k) Submitter Information | |||
|---|---|---|---|
| 510(k) Submitter Name | Marc Sanchez | ||
| Company Name | Contract In-House Counsel & Consultants, LLC (d/b/a FDA Atty) | ||
| Telephone | 202 765 4491 | ||
| msanchez@fdaatty.com |
| Device Information | |
|---|---|
| Device Name | Contour P-Insert System |
| Classification Name | a) Drill, bone, powered |
| b) Scaler, ultrasonic | |
| Product Code | DZI, ELC |
| Device Classification Panel | OHT1/DHT1B (Dental Devices) |
| Device Classification | Class II |
Predicate Devices
| Predicate Device Name | Predicate Device Sponsor | Product Code | 510(k) No. | |
|---|---|---|---|---|
| Surgystar | Predicate Device | Dmetec Co. Ltd. | DZI | K113152 |
| Diamond Coated | ||||
| Inserts | Reference Device 1 | Dentsply | ||
| International | ELC | K030111 | ||
| Piezosurgery Plus | Reference Device 2 | Mectorn S.p.a. | JDX, DZI, ERL, | |
| HBE, HWE | K153743 |
4
Device Description
The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:
-
CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not. -
CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.
-
CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.
During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.
Indications for Use
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgesy system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following uses:
-
- Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
-
- Soft tissue debridement and removal, particularly in intrabony lesions.
5
Technological Characteristics
| Characteristic | Subject Device | Predicate
Device
K113152 | Reference Device 1
K030111 | Reference Device
2
K153743 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Contour P-Insert System
(CPIS) | Surgystar | Diamond Coated Inserts | Piezosurgery Plus |
| Indications
for Use | 1) Surgical procedures
including osteotomy,
osteoplasty, periodontal
surgery and implantation.
2) Soft tissue debridement
and removal, particularly
in intrabony lesions. | 1) in surgical
procedures
including
osteotomy,
osteoplasty,
periodontal
surgery and
implantation. | 1) Removal of extremely
tenacious deposits of
calculus in both non-surgical
and surgically exposed
cases.
2) Removal of overhangs and
re-contouring of dental
restorations (amalgam, gold,
composite, acrylic and
porcelain) in both non-surgical
and surgically exposed cases.
3) Soft tissue debridement -
removal of tissue tags,
particularly in intrabony
lesions | 1) Ultrasonic
surgical system
consisting of
handpieces and
associated tips
for osteotomy,
osteoplasty and
drilling in a
variety of surgical
procedures |
| Compatibility &
Functionality | The user assembled CPIS
inserts are attached to the
male thread on the distal end
of the Dmetec handpiece. | The DSPS
inserts are
attached the
male thread on
the distal end of
the Surgystar
handpiece | NA - compatibility and
functionality of the CPIS
required with Predicate Device
only | NA - compatibility
and functionality
of the CPIS
required with
Predicate Device
only |
6
| Characteristic | Subject Device | Predicate Device
K113152 | Reference Device 1
K030111 | Reference Device 2
K153743 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Design | Insert:
End-User assembled
CPIS Inserts are created
from one shaft and one tip.
Two CPIS Shaft Designs:
Rigid 431 stainless steel
shaft-like piece with a
distal segment angulation
of 69.5 degrees (Model 45)
or 90 degrees (Model 90)
in relation to the long axis
of the shaft.
Three CPIS Tip Designs:
Triangular, non-stepped
pyramid (Model Tri)
Stepped cone (Model
WC) Four-sided stepped
pyramid (Model QT) | The DSPS inserts
do not have
components - they
are a single unit.
DSPS metal insert
with a saw-toothed
distal working end
with 3 sharp points.
DSPS insert with a
ball shaped distal
working end that
is coated in
diamond grit. | The Diamond Coated
inserts do not have
components - they
are a single unit.
This is an
industry-typical
magnetostrictive
scaler insert with an
arch-shaped
working end with
the terminal distal
end coated with
diamond grit. | Metal inserts
designed and
configured to cut
and drill bone. |
| Sterilization
State | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Supplied sterile |
| Sterilization
Method (prior
to use) | Steam Sterilization | Steam sterilization | Steam sterilization | EO sterilization |
| Insert
Materials | Shaft:
431 Stainless Steel
Tip
PEEK | Stainless Steel of
unspecified type | Diamond & Nickel
(known materials) | Insert
Titanium alloy,
316/316L stainless
steel,
Protective Sleeve
PEEK |
Non-Clinical Test Reports - Applicable Standards
The following tests were performed on the Contour P-Insert System and the test results show that the subject device is substantially equivalent to the predicate and reference devices:
| Test Name | Standard |
|---|---|
| In Vitro Cytotoxicity Test of PEEK | ISO10993-5:2009 (Biological evaluation of medical devices |
| — Part 5: Tests for in vitro cytotoxicity) | |
| Skin Sensitization Test of PEEK | ISO10993-10:2010 (Biological evaluation of medical |
| devices — Part 10: Tests for skin sensitization) | |
| Intracutaneous Reactivity Test of PEEK | ISO10993-10:2010 (Biological evaluation of medical |
| devices — Part 10: Tests for skin sensitization) | |
| Acute Systemic Toxicity of PEEK | ISO10993-11:2017 (Biological evaluation of medical |
| devices — Part 11: Tests for systemic toxicity) | |
| Pyrogen Test of PEEK | ISO10993-11:2017 (Biological evaluation of medical |
| devices — Part 11: Tests for systemic toxicity) | |
| In Vitro Hemolytic Properties Test of PEEK | ISO10993-4:2017 (Biological evaluation of medical devices |
| — Part 4: Selection of tests for interactions with blood) | |
| Complement Activity (C3a,SC5b-9) Test of | |
| PEEK | ISO10993-4:2017 (Biological evaluation of medical devices |
| — Part 4: Selection of tests for interactions with blood) | |
| Sterilization Validation (including drying | |
| validation) | ISO17665 - 1:2006 / (R)2013 (Sterilization of healthcare |
| products — Moist Heat — Part 1 Requirements for the | |
| development, validation and routine control of a sterilization | |
| process for medical devices) | |
| ISO14937:2009 / (R)2013 (Sterilization of health care | |
| products — General requirements for characterization of a | |
| sterilizing agent and the development, validation and | |
| routine control of a sterilization process for medical | |
| devices) | |
| ISO11138-3:2017 (Sterilization of health care products — | |
| Biological indicators – Part 3: Biological indicators for moist | |
| heat sterilization processes) | |
| ANSI/AAMI ST79:2017 (Comprehensive guide to steam | |
| sterilization and sterility assurance is health care facilities) | |
| CPIS Functionality and Efficacy Report | N/A - No consensus standards exist for this test. Relevant |
| literature and the standard of care are applicable. | |
| Tooth Surface Damage Study | N/A - No consensus standards exist for this test. Relevant |
| literature and the standard of care are applicable. |
7
The following tests were performed to determine the compatibility, functionality and performance of the CPIS. Five tests were performed on the subject device. As no written ISO or other consensus standards are applicable for the aforementioned tests, the peer-reviewed published literature and standard of care is cited as applicable in the study reports.
-
- Test Objective: Determination if the CPIS is compatible with the predicate device DSPS torque wrench accessory.
Outcome: The DSPS torque wrench fit, engaged, retained and easily disengaged from 100% of the CPIS samples.
- Test Objective: Determination if the CPIS is compatible with the predicate device DSPS torque wrench accessory.
8
Conclusion: This test demonstrates the compatibility of the DSPS torque wrench with the CPIS, and the Substantial Equivalence of the CPIS with the Predicate Device DSPS inserts due to the consistent fit of the DSPS torque wrench on the CPIS shaft square connector which is critical for proper function of the CPIS when connected to the DSPS.
Test Obiective: Determination if the CPIS shaft proximal female threaded connector is compatible with the predicate DSPS handpiece distal end male threaded connector. Outcome: No loosening of the CPIS inserts from the DSPS handpiece was observed in 100% of samples.
Conclusion: This test demonstrates the compatibility of the CPIS with the DSPS handpiece and the Substantial Equivalence of the CPIS with the Predicate Device DSPS, Specifically, the CPIS fits the Predicate Device DSPS handpiece distal male threaded connector and remains securely attached during use.
-
- Test Objective: Determination if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's indications for use: soft tissue debridement and periodontal surgery
Outcome: For all samples in all groups, soft tissue was effectively debrided to expose all intended root surfaces.
- Test Objective: Determination if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's indications for use: soft tissue debridement and periodontal surgery
Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "soft tissue debridement" and "periodontal surgery"; therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices.
-
- Test Objective: Determine if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's for use of: osteotomy. osteoplasty and periodontal surgery.
Outcome: For all samples in all groups, more than 1mm of bone, but less than 3mm of bone, was removed from around all Mock Resorptive Lesions as intended.
- Test Objective: Determine if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's for use of: osteotomy. osteoplasty and periodontal surgery.
Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "osteotomy, osteoplasty, and periodontal surgery": therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices.
-
- Test Objective: Determine if the CPIS PEEK tips and the DSPS inserts damage tooth surfaces._
Outcome: In all cases, the CPIS QT PEEK tip did not cause any discernible tooth surface damage, while both DSPS inserts caused extensive tooth surface damage. Conclusion: This test demonstrates that the CPIS is safe for use when in contact with tooth structure while the DSPS inserts tested are not safe for use in contact with tooth structure; therefore, the CPIS is superior to the Predicate Device DSPS inserts tested.
- Test Objective: Determine if the CPIS PEEK tips and the DSPS inserts damage tooth surfaces._
Conclusion
The documentation demonstrates that the Contour P-Insert System (CPIS) is substantially equivalent to the predicate and reference devices. It is further concluded that the CPIS is "as safe and effective" as the predicate (confirming SE) as an accessory to the DSPS to carry out the stated indications for use of: osteotomy, osteoplasty soft tissue debridement and periodontal surqery. These conclusions are based on the similarities in intended use, principles of operation, compatibility & functionality, and sterilization method.
9
Any differences in materials, design, or geometry have nominal to no impact on safety and do not raise new or different questions of efficacy as clearly demonstrated by the non-clinical studies included with this 510(k) submission.